FDA recall, Apr 2, 2026, Moderate risk

Burlington Medical Radiation Protection Apparel

Burlington Medical BAT Coverage may degrade over time, decreasing its lifespan.

Summary by Recall Canary from the FDA notice

Burlington Medical, LLC of Newport News, Virginia, recalled multiple Burlington Medical products due to a potential for attenuation degradation over time, decreasing the lifespan. The recall began on February 11, 2026, and was added to the FDA's Enforcement Report on April 2, 2026. Distribution was nationwide in the US and international to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
Talk to your health care provider before you stop using it.

Is yours affected?

13 products

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

Burlington Medical, Wrap Aprons.
UDI-DI
00840331297683
00840331297690
00840331258721
00840331258738
00840331258745
00840331258752
00840331258769
00840331258776
00840331258783
00840331258790
00840331258806
00840331258813
00840331258820
00840331258837
00840331258844
00840331258851
00840331258868
00840331270044
00840331270051
00840331259049
00840331259056
00840331259063
00840331259087
00840331259094
00840331259100
00840331259117
00840331259124
00840331259131
00840331259148
00840331259155
00840331259162
00840331270105
00840331270112
00840331259209
00840331259223
00840331259247
00840331259254
00840331259261
00840331259278
00840331259292
00840331259308
00840331259315
00840331259322
00840331259339
00840331259346
00840331270167
00840331270174
00197513001126
00197513007906
00197513007890
00197513007043
00197513007036
00197513010210
00197513010203
00197513009351
00197513009344
00840331262476
00840331262483
00840331262490
00840331262506
00840331262513
00840331262520
00840331262537
00840331262544
00840331262551
00840331262568
00840331262575
00840331262582
00840331262599
00840331262605
00840331262612
00840331270068
00840331270075
00840331262797
00840331262803
00840331262834
00840331262841
00840331262865
00840331262872
00840331262889
00840331262896
00840331262902
00840331262919
00840331270129
00840331270136
00840331262964
00840331262995
00840331263008
00840331263015
00840331263022
00840331263046
00840331263053
00840331263077
00840331270181
00840331270198
00197513000594
00840331266207
00840331266214
00840331266245
00840331266252
00840331266269
00840331266283
00840331266306
00840331266313
00840331266320
00840331266337
00840331266344
00840331266276
00840331270082
00840331270099
00840331266566
00840331266573
00840331266580
00840331266597
00840331266603
00840331266634
00840331266641
00840331270143
00840331270150
00840331266740
00840331270211
00840331270204
00197513000587
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8EURO; UDI-DI (Product Code): 00840331297683 (WRAPC8-C8EURO-LF ), 00840331297683 (WRAPC8-C8EURO-LM ), 00840331297683 (WRAPC8-C8EURO-MF ), 00840331297683 (WRAPC8-C8EURO-MM ), 00840331297683 (WRAPC8-C8EURO-SF ), 00840331297683 (WRAPC8-C8EURO-SM ), 00840331297683 (WRAPC8-C8EURO-XLM ), 00840331297683 (WRAPT18-C8EURO-LF ), 00840331297683 (WRAPT18-C8EURO-LM ), 00840331297683 (WRAPT18-C8EURO-MM ), 00840331297683 (WRAPT18-C8EURO-PLUS ), 00840331297683 (WRAPT18-C8EURO-SM ). 2. Model Number: C8F111; UDI-DI (Product Code): 00840331297690 (WRAPT18-C8F111-MM). 3. Model Number: R8EURO; UDI-DI (Product Code): 00840331258721 (WRAPC18-R8EURO-2XF ), 00840331258738 (WRAPC18-R8EURO-2XM ), 00840331258745 (WRAPC18-R8EURO-3XF ), 00840331258752 (WRAPC18-R8EURO-3XM ), 00840331258769 (WRAPC8-R8EURO-LF ), 00840331258776 (WRAPC8-R8EURO-LM ), 00840331258783 (WRAPC8-R8EURO-MF ), 00840331258790 (WRAPC8-R8EURO-MM ), 00840331258806 (WRAPC8-R8EURO-PLUS ), 00840331258813 (WRAPC8-R8EURO-SF ), 00840331258820 (WRAPC8-R8EURO-SM ), 00840331258837 (WRAPC8-R8EURO-XLF ), 00840331258844 (WRAPC8-R8EURO-XLM ), 00840331258851 (WRAPC8-R8EURO-XSF ), 00840331258868 (WRAPC8-R8EURO-XSM ), 00840331258769 (WRAPS8-R8EURO-LF ), 00840331258776 (WRAPS8-R8EURO-LM ), 00840331258783 (WRAPS8-R8EURO-MF ), 00840331258790 (WRAPS8-R8EURO-MM ), 00840331258813 (WRAPS8-R8EURO-SF ), 00840331258820 (WRAPS8-R8EURO-SM ), 00840331258837 (WRAPS8-R8EURO-XLF ), 00840331258844 (WRAPS8-R8EURO-XLM ), 00840331270044 (WRAPT18-R8EURO-LF ), 00840331270051 (WRAPT18-R8EURO-LM ), 00840331270051 (WRAPT18-R8EURO-MF ), 00840331270051 (WRAPT18-R8EURO-MM ), 00840331270044 (WRAPT18-R8EURO-PLUS ), 00840331270044 (WRAPT18-R8EURO-SF ), 00840331270051 (WRAPT18-R8EURO-SM ), 00840331270044 (WRAPT18-R8EURO-XLF ), 00840331270051 (WRAPT18-R8EURO-XLM ), 00840331270051 (WRAPT18-R8EURO-XSM ), 00840331270044 (WRAPT28-R8EURO-2XF ), 00840331270051 (WRAPT28-R8EURO-2XM ), 00840331270044 (WRAPT28-R8EURO-3XF ), 00840331270051 (WRAPT28-R8EURO-3XM ), 00840331270044 (WRAPT28-R8EURO-4XF ), 00840331270051 (WRAPT28-R8EURO-4XM ), 00840331270044 (WRAPT28-R8EURO-5XF ), 00840331270051 (WRAPT28-R8EURO-5XM ), 00840331270044 (WRAPT38-R8EURO-6XF ), 00840331270051 (WRAPT38-R8EURO-6XM ), 00840331270044 (WRAPT38-R8EURO-7XF ), 00840331270051 (WRAPT38-R8EURO-7XM ), 00840331270044 (WRAPT38-R8EURO-8XF ), 00840331270051 (WRAPT38-R8EURO-8XM ), None (IWRAPC8-R8EURO-LFR ), None (IWRAPC8-R8EURO-MFR ), None (IWRAPC8-R8EURO-PLUSL ), None (IWRAPC8-R8EURO-SFS ). 4. Model Number: R8F111; UDI-DI (Product Code): 00840331259049 (WRAPC18-R8F111-2XF ), 00840331259056 (WRAPC18-R8F111-2XM ), 00840331259063 (WRAPC18-R8F111-3XF ), 00840331259087 (WRAPC8-R8F111-LF ), 00840331259094 (WRAPC8-R8F111-LM ), 00840331259100 (WRAPC8-R8F111-MF ), 00840331259117 (WRAPC8-R8F111-MM ), 00840331259124 (WRAPC8-R8F111-PLUS ), 00840331259131 (WRAPC8-R8F111-SF ), 00840331259148 (WRAPC8-R8F111-SM ), 00840331259155 (WRAPC8-R8F111-XLF ), 00840331259162 (WRAPC8-R8F111-XLM ), 00840331270105 (WRAPT18-R8F111-LF ), 00840331270112 (WRAPT18-R8F111-LM ), 00840331270105 (WRAPT18-R8F111-MF ), 00840331270112 (WRAPT18-R8F111-MM ), 00840331270105 (WRAPT18-R8F111-PLUS ), 00840331270105 (WRAPT18-R8F111-SF ), 00840331270112 (WRAPT18-R8F111-SM ), 00840331270105 (WRAPT18-R8F111-XLF ), 00840331270112 (WRAPT18-R8F111-XLM ), 00840331270112 (WRAPT18-R8F111-XSM ), 00840331270105 (WRAPT28-R8F111-2XF ), 00840331270112 (WRAPT28-R8F111-2XM ), 00840331270105 (WRAPT28-R8F111-3XF ), 00840331270112 (WRAPT28-R8F111-3XM ), 00840331270105 (WRAPT28-R8F111-4XF ), 00840331270112 (WRAPT28-R8F111-4XM ), 00840331270105 (WRAPT28-R8F111-5XF ), 00840331270112 (WRAPT28-R8F111-5XM ), 00840331270105 (WRAPT38-R8F111-6XF ), 00840331270112 (WRAPT38-R8F111-6XM ), 00840331270112 (WRAPT38-R8F111-8XM ), None (IWRAPC8-R8F111-MML ). 5. Model Number: R8F112; UDI-DI (Product Code): 00840331259209 (WRAPC18-R8F112-2XF ), 00840331259223 (WRAPC18-R8F112-3XF ), 00840331259247 (WRAPC8-R8F112-LF ), 00840331259254 (WRAPC8-R8F112-LM ), 00840331259261 (WRAPC8-R8F112-MF ), 00840331259278 (WRAPC8-R8F112-MM ), 00840331259292 (WRAPC8-R8F112-SF ), 00840331259308 (WRAPC8-R8F112-SM ), 00840331259315 (WRAPC8-R8F112-XLF ), 00840331259322 (WRAPC8-R8F112-XLM ), 00840331259339 (WRAPC8-R8F112-XSF ), 00840331259346 (WRAPC8-R8F112-XSM ), 00840331270167 (WRAPT18-R8F112-LF ), 00840331270174 (WRAPT18-R8F112-LM ), 00840331270167 (WRAPT18-R8F112-MF ), 00840331270174 (WRAPT18-R8F112-MM ), 00840331270167 (WRAPT18-R8F112-PLUS ), 00840331270167 (WRAPT18-R8F112-SF ), 00840331270174 (WRAPT18-R8F112-SM ), 00840331270167 (WRAPT18-R8F112-XLF ), 00840331270174 (WRAPT18-R8F112-XLM ), 00840331270174 (WRAPT18-R8F112-XSM ), 00840331270174 (WRAPT28-R8F112-2XM ), 00840331270167 (WRAPT28-R8F112-3XF ), 00840331270174 (WRAPT28-R8F112-4XM ), 00840331270167 (WRAPT28-R8F112-5XF ), 00840331270105 (WRAPT38-R8F112-6XF ), 00840331270105 (WRAPT38-R8F112-7XF ), 00840331270112 (WRAPT38-R8F112-7XM ), None (IWRAPC8-R8F112-2XML ), None (IWRAPC8-R8F112-LFR ), None (IWRAPC8-R8F112-LMR ), None (IWRAPC8-R8F112-MFR ), None (IWRAPC8-R8F112-MFS ), None (IWRAPC8-R8F112-MMR ), None (IWRAPC8-R8F112-MMS ), None (IWRAPC8-R8F112-PLUSL ), None (IWRAPC8-R8F112-PLUSR ), None (IWRAPC8-R8F112-SFS ), None (IWRAPC8-R8F112-SMS ), None (IWRAPC8-R8F112-XLFL ), None (IWRAPC8-R8F112-XLML ), None (IWRAPC8-R8F112-XSFS ), None (IWRAPC8-R8F112-XSMS ), None (IWRAPC8-R8F112-MML ). 6. Model Number: R8P600; UDI-DI (Product Code): 00197513001126 (PWRAPC8-R8P600-MD ). 7. Model Number: R8W113; UDI-DI (Product Code): 00197513007906 (WRAPC18-R8W113-2XF ), 00197513007890 (WRAPC18-R8W113-2XM ), 00197513007043 (WRAPC8-R8W113-MF ), 00197513007036 (WRAPC8-R8W113-MM ). 8. Model Number: R8W114; UDI-DI (Product Code): 00197513010210 (WRAPC18-R8W114-2XF ), 00197513010203 (WRAPC18-R8W114-2XM ), 00197513009351 (WRAPC8-R8W114-MF ), 00197513009344 (WRAPC8-R8W114-MM ). 9. Model Number: S8EURO; UDI-DI (Product Code): 00840331262476 (WRAPC18-S8EURO-2XF ), 00840331262483 (WRAPC18-S8EURO-2XM ), 00840331262490 (WRAPC18-S8EURO-3XF ), 00840331262506 (WRAPC18-S8EURO-3XM ), 00840331262513 (WRAPC8-S8EURO-LF ), 00840331262520 (WRAPC8-S8EURO-LM ), 00840331262537 (WRAPC8-S8EURO-MF ), 00840331262544 (WRAPC8-S8EURO-MM ), 00840331262551 (WRAPC8-S8EURO-PLUS ), 00840331262568 (WRAPC8-S8EURO-SF ), 00840331262575 (WRAPC8-S8EURO-SM ), 00840331262582 (WRAPC8-S8EURO-XLF ), 00840331262599 (WRAPC8-S8EURO-XLM ), 00840331262605 (WRAPC8-S8EURO-XSF ), 00840331262612 (WRAPC8-S8EURO-XSM ), 00840331262513 (WRAPS8-S8EURO-LF ), 00840331262520 (WRAPS8-S8EURO-LM ), 00840331262537 (WRAPS8-S8EURO-MF ), 00840331262544 (WRAPS8-S8EURO-MM ), 00840331262568 (WRAPS8-S8EURO-SF ), 00840331262575 (WRAPS8-S8EURO-SM ), 00840331262599 (WRAPS8-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-LF ), 00840331270075 (WRAPT18-S8EURO-LM ), 00840331270068 (WRAPT18-S8EURO-MF ), 00840331270075 (WRAPT18-S8EURO-MM ), 00840331270068 (WRAPT18-S8EURO-PLUS ), 00840331270068 (WRAPT18-S8EURO-SF ), 00840331270075 (WRAPT18-S8EURO-SM ), 00840331270068 (WRAPT18-S8EURO-XLF ), 00840331270075 (WRAPT18-S8EURO-XLM ), 00840331270068 (WRAPT18-S8EURO-XSF ), 00840331270075 (WRAPT18-S8EURO-XSM ), 00840331270068 (WRAPT28-S8EURO-2XF ), 00840331270075 (WRAPT28-S8EURO-2XM ), 00840331270068 (WRAPT28-S8EURO-3XF ), 00840331270075 (WRAPT28-S8EURO-3XM ), 00840331270068 (WRAPT28-S8EURO-4XF ), 00840331270075 (WRAPT28-S8EURO-4XM ), 00840331270068 (WRAPT28-S8EURO-5XF ), 00840331270075 (WRAPT28-S8EURO-5XM ), 00840331270068 (WRAPT38-S8EURO-6XF ), 00840331270075 (WRAPT38-S8EURO-6XM ), 00840331270068 (WRAPT38-S8EURO-7XF ), 00840331270075 (WRAPT38-S8EURO-7XM ), 00840331270068 (WRAPT38-S8EURO-8XF ), 00840331270075 (WRAPT38-S8EURO-8XM ). 10. Model Number: S8F111; UDI-DI (Product Code): 00840331262797 (WRAPC18-S8F111-2XF ), 00840331262803 (WRAPC18-S8F111-2XM ), 00840331262834 (WRAPC8-S8F111-LF ), 00840331262841 (WRAPC8-S8F111-LM ), 00840331262841 (WRAPC8-S8F111-MF ), 00840331262865 (WRAPC8-S8F111-MM ), 00840331262872 (WRAPC8-S8F111-PLUS ), 00840331262889 (WRAPC8-S8F111-SF ), 00840331262896 (WRAPC8-S8F111-SM ), 00840331262902 (WRAPC8-S8F111-XLF ), 00840331262919 (WRAPC8-S8F111-XLM ), 00840331270129 (WRAPT18-S8F111-LF ), 00840331270136 (WRAPT18-S8F111-LM ), 00840331270129 (WRAPT18-S8F111-MF ), 00840331270136 (WRAPT18-S8F111-MM ), 00840331270129 (WRAPT18-S8F111-PLUS ), 00840331270129 (WRAPT18-S8F111-SF ), 00840331270136 (WRAPT18-S8F111-SM ), 00840331270129 (WRAPT18-S8F111-XLF ), 00840331270136 (WRAPT18-S8F111-XLM ), 00840331270136 (WRAPT18-S8F111-XSM ), 00840331270129 (WRAPT28-S8F111-2XF ), 00840331270136 (WRAPT28-S8F111-2XM ), 00840331270129 (WRAPT28-S8F111-3XF ), 00840331270136 (WRAPT28-S8F111-3XM ), 00840331270129 (WRAPT28-S8F111-4XF ), 00840331270136 (WRAPT28-S8F111-4XM ), 00840331270129 (WRAPT28-S8F111-5XF ), 00840331270136 (WRAPT28-S8F111-5XM ), 00840331270129 (WRAPT38-S8F111-6XF ), 00840331270136 (WRAPT38-S8F111-6XM ), 00840331270129 (WRAPT38-S8F111-8XF ), 00840331270136 (WRAPT38-S8F111-8XM ). 11. Model Number: S8F112; UDI-DI (Product Code): 00840331262964 (WRAPC18-S8F112-2XM ), 00840331262995 (WRAPC8-S8F112-LF ), 00840331263008 (WRAPC8-S8F112-LM ), 00840331263015 (WRAPC8-S8F112-MF ), 00840331263022 (WRAPC8-S8F112-MM ), 00840331263046 (WRAPC8-S8F112-SF ), 00840331263053 (WRAPC8-S8F112-SM ), 00840331263077 (WRAPC8-S8F112-XLM ), 00840331270181 (WRAPT18-S8F112-LF ), 00840331270198 (WRAPT18-S8F112-LM ), 00840331270181 (WRAPT18-S8F112-MF ), 00840331270198 (WRAPT18-S8F112-MM ), 00840331270181 (WRAPT18-S8F112-PLUS ), 00840331270198 (WRAPT18-S8F112-SM ), 00840331270181 (WRAPT18-S8F112-XLF ), 00840331270198 (WRAPT18-S8F112-XLM ), 00840331270181 (WRAPT28-S8F112-2XF ), 00840331270198 (WRAPT28-S8F112-2XM ), 00840331270198 (WRAPT28-S8F112-3XM ), 00840331270181 (WRAPT28-S8F112-4XF ), 00840331270198 (WRAPT28-S8F112-5XM ). 12. Model Number: S8W113; UDI-DI (Product Code): 00197513000594 (WRAPT28-S8W113-3XF ). 13. Model Number: U8EURO; UDI-DI (Product Code): 00840331266207 (WRAPC18-U8EURO-2XF ), 00840331266214 (WRAPC18-U8EURO-2XM ), 00840331266245 (WRAPC8-U8EURO-LF ), 00840331266252 (WRAPC8-U8EURO-LM ), 00840331266269 (WRAPC8-U8EURO-MF ), 00840331266269 (WRAPC8-U8EURO-MM ), 00840331266283 (WRAPC8-U8EURO-PLUS ), 00840331266306 (WRAPC8-U8EURO-SM ), 00840331266313 (WRAPC8-U8EURO-XLF ), 00840331266320 (WRAPC8-U8EURO-XLM ), 00840331266337 (WRAPC8-U8EURO-XSF ), 00840331266344 (WRAPC8-U8EURO-XSM ), 00840331266245 (WRAPS8-U8EURO-LF ), 00840331266252 (WRAPS8-U8EURO-LM ), 00840331266269 (WRAPS8-U8EURO-MF ), 00840331266276 (WRAPS8-U8EURO-MM ), 00840331266306 (WRAPS8-U8EURO-SM ), 00840331266320 (WRAPS8-U8EURO-XLM ), 00840331270082 (WRAPT18-U8EURO-LF ), 00840331270099 (WRAPT18-U8EURO-LM ), 00840331270082 (WRAPT18-U8EURO-MF ), 00840331270099 (WRAPT18-U8EURO-MM ), 00840331270082 (WRAPT18-U8EURO-PLUS ), 00840331270082 (WRAPT18-U8EURO-SF ), 00840331270099 (WRAPT18-U8EURO-SM ), 00840331270082 (WRAPT18-U8EURO-XLF ), 00840331270099 (WRAPT18-U8EURO-XLM ), 00840331270099 (WRAPT18-U8EURO-XSM ), 00840331270082 (WRAPT28-U8EURO-2XF ), 00840331270099 (WRAPT28-U8EURO-2XM ), 00840331270082 (WRAPT28-U8EURO-3XF ), 00840331270099 (WRAPT28-U8EURO-3XM ), 00840331270082 (WRAPT28-U8EURO-4XF ), 00840331270099 (WRAPT28-U8EURO-4XM ), 00840331270082 (WRAPT28-U8EURO-5XF ), 00840331270099 (WRAPT28-U8EURO-5XM ), 00840331270082 (WRAPT38-U8EURO-6XF ), 00840331270099 (WRAPT38-U8EURO-6XM ), 00840331270082 (WRAPT38-U8EURO-7XF ), 00840331270099 (WRAPT38-U8EURO-7XM ), 00840331270099 (WRAPT38-U8EURO-8XM ). 14. Model Number: U8F111; UDI-DI (Product Code): 00840331266566 (WRAPC8-U8F111-LF ), 00840331266573 (WRAPC8-U8F111-LM ), 00840331266580 (WRAPC8-U8F111-MF ), 00840331266597 (WRAPC8-U8F111-MM ), 00840331266603 (WRAPC8-U8F111-PLUS ), 00840331266634 (WRAPC8-U8F111-XLF ), 00840331266641 (WRAPC8-U8F111-XLM ), 00840331270143 (WRAPT18-U8F111-LF ), 00840331270150 (WRAPT18-U8F111-LM ), 00840331270143 (WRAPT18-U8F111-MF ), 00840331270150 (WRAPT18-U8F111-MM ), 00840331270143 (WRAPT18-U8F111-PLUS ), 00840331270150 (WRAPT18-U8F111-SM ), 00840331270143 (WRAPT18-U8F111-XLF ), 00840331270150 (WRAPT18-U8F111-XLM ), 00840331270143 (WRAPT28-U8F111-2XF ), 00840331270150 (WRAPT28-U8F111-2XM ), 00840331270150 (WRAPT28-U8F111-3XM ), 00840331270143 (WRAPT28-U8F111-4XF ), 00840331270150 (WRAPT28-U8F111-4XM ), 00840331270143 (WRAPT28-U8F111-5XF ), 00840331270143 (WRAPT38-U8F111-6XF ), 00840331270150 (WRAPT38-U8F111-6XM ), 00840331270143 (WRAPT38-U8F111-7XF ), None (IWRAPC8-U8F111-2XMR ), None (IWRAPC8-U8F111-LMR ), None (IWRAPC8-U8F111-MMR ), None (IWRAPC8-U8F111-SMR ), None (IWRAPC8-U8F111-XLMR ). 15. Model Number: U8F112; UDI-DI (Product Code): 00840331266740 (WRAPC8-U8F112-MF ), 00840331270211 (WRAPT18-U8F112-MM ), 00840331270211 (WRAPT18-U8F112-XLM ), 00840331270211 (WRAPT28-U8F112-4XM ), 00840331270204 (WRAPT28-U8F112-5XF ), None (IWRAPC8-U8F112-2XMR ), None (IWRAPC8-U8F112-LMR ), None (IWRAPC8-U8F112-MMR ), None (IWRAPC8-U8F112-SMR ), None (IWRAPC8-U8F112-XLMR ), None (IWRAPC8-U8F112-XLMXL ). 16. Model Number: U8W113; UDI-DI (Product Code): 00197513000587 (WRAPT28-U8W113-3XF ). 17. Model Number: R8EURO; UDI-DI (Product Code): None (IWRAPC8-R8EURO-LMR).
Burlington Medical, Leg Wraps.
UDI-DI
00840331272079
00840331272086
00840331272055
00840331272116
00840331272123
00840331272093
00840331272109
00840331272154
00840331272161
00840331272147
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8LGW1; UDI-DI (Product Code): 00840331272079 (LGW8SET-R8LGW1). 2. Model Number: R8LGW2; UDI-DI (Product Code): 00840331272086 (LGW8SET-R8LGW2). 3. Model Number: R8LGW3; UDI-DI (Product Code): 00840331272055 (LGW8SET-R8LGW3). 4. Model Number: S8LGW1; UDI-DI (Product Code): 00840331272116 (LGW8SET-S8LGW1). 5. Model Number: S8LGW2; UDI-DI (Product Code): 00840331272123 (LGW8SET-S8LGW2). 6. Model Number: S8LGW3; UDI-DI (Product Code): 00840331272093 (LGW8SET-S8LGW3). 7. Model Number: S8LGW4; UDI-DI (Product Code): 00840331272109 (LGW8SET-S8LGW4). 8. Model Number: U8LGW1; UDI-DI (Product Code): 00840331272154 (LGW8SET-U8LGW1). 9. Model Number: U8LGW2; UDI-DI (Product Code): 00840331272161 (LGW8SET-U8LGW2). 10. Model Number: U8LGW4; UDI-DI (Product Code): 00840331272147 (LGW8SET-U8LGW4).
Burlington Medical, Half Aprons.
UDI-DI
00840331272291
00840331272314
00840331272338
00840331272345
00840331272352
00840331272369
00840331272376
00840331272383
00840331272390
00840331272406
00840331272420
00840331272413
00840331272451
00840331272475
00840331272482
00840331272499
00840331272505
00840331272512
00840331272529
00840331272536
00840331272543
00840331272567
00840331272635
00840331272642
00840331272666
00840331272680
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8HALF1B; UDI-DI (Product Code): 00840331272291 (HALF18-R8HALF1B). 2. Model Number: R8HALF1H; UDI-DI (Product Code): 00840331272314 (HALF18-R8HALF1H). 3. Model Number: R8HALF2B; UDI-DI (Product Code): 00840331272338 (HALF28-R8HALF2B). 4. Model Number: R8HALF2H; UDI-DI (Product Code): 00840331272345 (HALF28-R8HALF2H). 5. Model Number: R8HALF3B; UDI-DI (Product Code): 00840331272352 (HALF38-R8HALF3B). 6. Model Number: R8HALF3H; UDI-DI (Product Code): 00840331272369 (HALF38-R8HALF3H). 7. Model Number: R8HALF4B; UDI-DI (Product Code): 00840331272376 (HALF48-R8HALF4B). 8. Model Number: R8HALF4H; UDI-DI (Product Code): 00840331272383 (HALF48-R8HALF4H). 9. Model Number: R8HALF5B; UDI-DI (Product Code): 00840331272390 (HALF58-R8HALF5B). 10. Model Number: R8HALF5H; UDI-DI (Product Code): 00840331272406 (HALF58-R8HALF5H). 11. Model Number: R8HALF6B; UDI-DI (Product Code): 00840331272420 (HALF68-R8HALF6B). 12. Model Number: R8HALF6H; UDI-DI (Product Code): 00840331272352 (HALF68-R8HALF6H). 13. Model Number: R8HALFSETB; UDI-DI (Product Code): 00840331272413 (HALFSET8-R8HALFSETB). 14. Model Number: R8HALFSETH; UDI-DI (Product Code): 00840331272420 (HALFSET8-R8HALFSETH). 15. Model Number: S8HALF1H; UDI-DI (Product Code): 00840331272451 (HALF18-S8HALF1H). 16. Model Number: S8HALF2B; UDI-DI (Product Code): 00840331272475 (HALF28-S8HALF2B). 17. Model Number: S8HALF2H; UDI-DI (Product Code): 00840331272482 (HALF28-S8HALF2H). 18. Model Number: S8HALF3B; UDI-DI (Product Code): 00840331272499 (HALF38-S8HALF3B). 19. Model Number: S8HALF3H; UDI-DI (Product Code): 00840331272505 (HALF38-S8HALF3H). 20. Model Number: S8HALF4B; UDI-DI (Product Code): 00840331272512 (HALF48-S8HALF4B). 21. Model Number: S8HALF4H; UDI-DI (Product Code): 00840331272529 (HALF48-S8HALF4H). 22. Model Number: S8HALF5B; UDI-DI (Product Code): 00840331272536 (HALF58-S8HALF5B). 23. Model Number: S8HALF5H; UDI-DI (Product Code): 00840331272543 (HALF58-S8HALF5H). 24. Model Number: S8HALF6H; UDI-DI (Product Code): 00840331272499 (HALF68-S8HALF6H). 25. Model Number: S8HALFSETH; UDI-DI (Product Code): 00840331272567 (HALFSET8-S8HALFSETH). 26. Model Number: U8HALF3B; UDI-DI (Product Code): 00840331272635 (HALF38-U8HALF3B). 27. Model Number: U8HALF3H; UDI-DI (Product Code): 00840331272642 (HALF38-U8HALF3H). 28. Model Number: U8HALF4H; UDI-DI (Product Code): 00840331272666 (HALF48-U8HALF4H). 29. Model Number: U8HALF5H; UDI-DI (Product Code): 00840331272680 (HALF58-U8HALF5H). 30. Model Number: U8HALF6H; UDI-DI (Product Code): 00840331272635 (HALF68-U8HALF6H).
Burlington Medical, Vest
UDI-DI
00840331297652
00840331297645
00840331259520
00840331259537
00840331259551
00840331259568
00840331259575
00840331259582
00840331259599
00840331259605
00840331259612
00840331259629
00840331259636
00840331259643
00840331259650
00840331269741
00840331269758
00840331259841
00840331259858
00840331259865
00840331259872
00840331259889
00840331259896
00840331259902
00840331259919
00840331259926
00840331259933
00840331259940
00840331259957
00840331259964
00840331259971
00840331259988
00840331269680
00840331269697
00840331260076
00840331260083
00840331260106
00840331260113
00840331260007
00840331269802
00840331260120
00840331261752
00840331261769
00840331261776
00840331261783
00840331261790
00840331261806
00840331261813
00840331261820
00840331261837
00840331261844
00840331261851
00840331261868
00840331261875
00840331261882
00840331261899
00840331269628
00840331269635
00840331262063
00840331262087
00840331262148
00840331269840
00840331269833
00840331263275
00840331263305
00840331263312
00840331263329
00840331263336
00840331263343
00840331263350
00840331263367
00840331263374
00840331263381
00840331263398
00840331269765
00840331269772
00840331263596
00840331263602
00840331263633
00840331263640
00840331263657
00840331263664
00840331263671
00840331263688
00840331263695
00840331263701
00840331263718
00840331269703
00840331269710
00840331263794
00840331263800
00840331263817
00840331263824
00840331263831
00840331269819
00840331265477
00840331265484
00840331265491
00840331265514
00840331265521
00840331265538
00840331265545
00840331265552
00840331265569
00840331265576
00840331265583
00840331265590
00840331265606
00840331265613
00840331269642
00840331269659
00840331265781
00840331265804
00840331269864
00840331267044
00840331267051
00840331267075
00840331267099
00840331267105
00840331267112
00840331267136
00840331269796
00840331269789
00840331267013
00840331267365
00840331267372
00840331267389
00840331267396
00840331267402
00840331267419
00840331267433
00840331267440
00840331267464
00840331269727
00840331269734
00840331267556
00840331267563
00840331267594
00840331267525
00840331269826
00840331296136
00840331269215
00840331269222
00840331269253
00840331269260
00840331269277
00840331269284
00840331269291
00840331269307
00840331269314
00840331269321
00840331269338
00840331269352
00840331269666
00840331269673
00840331269536
00840331269543
00840331269901
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8PVEST; UDI-DI (Product Code): 00840331297652 (VESTC18-C8PVEST-2XM ), 00840331297652 (VESTC8-C8PVEST-LF ), 00840331297652 (VESTC8-C8PVEST-LM ), 00840331297652 (VESTC8-C8PVEST-MF ), 00840331297652 (VESTC8-C8PVEST-MM ), 00840331297652 (VESTC8-C8PVEST-SF ), 00840331297652 (VESTC8-C8PVEST-SM ), 00840331297652 (VESTC8-C8PVEST-XLM ), 00840331297652 (VESTT18-C8PVEST-LF ), 00840331297652 (VESTT18-C8PVEST-LM ), 00840331297652 (VESTT18-C8PVEST-MM ), 00840331297652 (VESTT18-C8PVEST-PLUS ), 00840331297652 (VESTT18-C8PVEST-SM ), 00840331297652 (VESTT28-C8PVEST-3XM ), 00840331297652 (VESTT28-C8PVEST-4XM ), 00840331297652 (VESTT28-C8PVEST-5XM ). 2. Model Number: C8VEST; UDI-DI (Product Code): 00840331297645 (VESTC18-C8VEST-2XM ), 00840331297645 (VESTC8-C8VEST-LF ), 00840331297645 (VESTC8-C8VEST-LM ), 00840331297645 (VESTC8-C8VEST-MF ), 00840331297645 (VESTC8-C8VEST-MM ), 00840331297645 (VESTC8-C8VEST-PLUS ), 00840331297645 (VESTC8-C8VEST-SF ), 00840331297645 (VESTC8-C8VEST-SM ), 00840331297645 (VESTC8-C8VEST-XLF ), 00840331297645 (VESTC8-C8VEST-XLM ), 00840331297645 (VESTC8-C8VEST-XSF ), 00840331297645 (VESTT18-C8VEST-LM ), 00840331297645 (VESTT18-C8VEST-MM ), 00840331297645 (VESTT18-C8VEST-SM ), 00840331297645 (VESTT18-C8VEST-XLM ), 00840331297645 (VESTT18-C8VEST-XSM ), 00840331297645 (VESTT28-C8VEST-2XM ), 00840331297645 (VESTT28-C8VEST-4XF ). 3. Model Number: R8FVEST; UDI-DI (Product Code): 00840331259520 (VESTC18-R8FVEST-2XF ), 00840331259537 (VESTC18-R8FVEST-2XM ), 00840331259551 (VESTC18-R8FVEST-3XM ), 00840331259568 (VESTC8-R8FVEST-LF ), 00840331259575 (VESTC8-R8FVEST-LM ), 00840331259582 (VESTC8-R8FVEST-MF ), 00840331259599 (VESTC8-R8FVEST-MM ), 00840331259605 (VESTC8-R8FVEST-PLUS ), 00840331259612 (VESTC8-R8FVEST-SF ), 00840331259629 (VESTC8-R8FVEST-SM ), 00840331259636 (VESTC8-R8FVEST-XLF ), 00840331259643 (VESTC8-R8FVEST-XLM ), 00840331259650 (VESTC8-R8FVEST-XSF ), 00840331269741 (VESTT18-R8FVEST-LF ), 00840331269758 (VESTT18-R8FVEST-LM ), 00840331269741 (VESTT18-R8FVEST-MF ), 00840331269758 (VESTT18-R8FVEST-MM ), 00840331269741 (VESTT18-R8FVEST-PLUS ), 00840331269741 (VESTT18-R8FVEST-SF ), 00840331269758 (VESTT18-R8FVEST-SM ), 00840331269741 (VESTT18-R8FVEST-XLF ), 00840331269758 (VESTT18-R8FVEST-XLM ), 00840331269758 (VESTT18-R8FVEST-XSM ), 00840331269741 (VESTT28-R8FVEST-2XF ), 00840331269758 (VESTT28-R8FVEST-2XM ), 00840331269741 (VESTT28-R8FVEST-3XF ), 00840331269758 (VESTT28-R8FVEST-3XM ), 00840331269741 (VESTT28-R8FVEST-4XF ), 00840331269758 (VESTT28-R8FVEST-4XM ), 00840331269741 (VESTT28-R8FVEST-5XF ), 00840331269758 (VESTT28-R8FVEST-5XM ), 00840331269741 (VESTT38-R8FVEST-6XF ), 00840331269758 (VESTT38-R8FVEST-6XM ), 00840331269741 (VESTT38-R8FVEST-8XF ), 00840331269758 (VESTT38-R8FVEST-8XM ), None (IVESTC8-R8FVEST-MFR ), None (IVESTC8-R8FVEST-MML ), None (IVESTC8-R8FVEST-LFL ), None (IVESTC8-R8FVEST-LFR ), None (IVESTC8-R8FVEST-LML ), None (IVESTC8-R8FVEST-MMR ), None (IVESTC8-R8FVEST-PLUSL ), None (IVESTC8-R8FVEST-SFR ), None (IVESTC8-R8FVEST-SFS ), None (IVESTC8-R8FVEST-SMR ), None (IVESTC8-R8FVEST-SMS ), None (IVESTC8-R8FVEST-XLML ), None (IVESTC8-R8FVEST-XSFS ), None (IVESTC8-R8FVEST-MMXL ), None (IVESTC8-R8FVEST-XLMXL ), None (IVESTC8-R8FVEST-LMR ), None (IVESTC8-R8FVEST-XSFR ), None (IVESTC8-R8FVEST-XSMR ). 4. Model Number: R8PVEST; UDI-DI (Product Code): None (IVESTC8-R8PVEST-LMR ), None (IVESTC8-R8PVEST-SMR ), 00840331259841 (VESTC18-R8PVEST-2XF ), 00840331259858 (VESTC18-R8PVEST-2XM ), 00840331259865 (VESTC18-R8PVEST-3XF ), 00840331259872 (VESTC18-R8PVEST-3XM ), 00840331259889 (VESTC8-R8PVEST-LF ), 00840331259896 (VESTC8-R8PVEST-LM ), 00840331259902 (VESTC8-R8PVEST-MF ), 00840331259919 (VESTC8-R8PVEST-MM ), 00840331259926 (VESTC8-R8PVEST-PLUS ), 00840331259933 (VESTC8-R8PVEST-SF ), 00840331259940 (VESTC8-R8PVEST-SM ), 00840331259957 (VESTC8-R8PVEST-XLF ), 00840331259964 (VESTC8-R8PVEST-XLM ), 00840331259971 (VESTC8-R8PVEST-XSF ), 00840331259988 (VESTC8-R8PVEST-XSM ), 00840331269680 (VESTT18-R8PVEST-LF ), 00840331269697 (VESTT18-R8PVEST-LM ), 00840331269680 (VESTT18-R8PVEST-MF ), 00840331269697 (VESTT18-R8PVEST-MM ), 00840331269680 (VESTT18-R8PVEST-PLUS ), 00840331269680 (VESTT18-R8PVEST-SF ), 00840331269697 (VESTT18-R8PVEST-SM ), 00840331269680 (VESTT18-R8PVEST-XLF ), 00840331269697 (VESTT18-R8PVEST-XLM ), 00840331269697 (VESTT18-R8PVEST-XSM ), 00840331269680 (VESTT28-R8PVEST-2XF ), 00840331269697 (VESTT28-R8PVEST-2XM ), 00840331269680 (VESTT28-R8PVEST-3XF ), 00840331269697 (VESTT28-R8PVEST-3XM ), 00840331269680 (VESTT28-R8PVEST-4XF ), 00840331269697 (VESTT28-R8PVEST-4XM ), 00840331269680 (VESTT28-R8PVEST-5XF ), 00840331269697 (VESTT28-R8PVEST-5XM ), 00840331269680 (VESTT38-R8PVEST-6XF ), 00840331269697 (VESTT38-R8PVEST-6XM ), 00840331269680 (VESTT38-R8PVEST-7XF ), 00840331269697 (VESTT38-R8PVEST-7XM ), 00840331269680 (VESTT38-R8PVEST-8XF ), 00840331269697 (VESTT38-R8PVEST-8XM ), None (IVESTC8-R8PVEST-LFR ), None (IVESTC8-R8PVEST-MFL ), None (IVESTC8-R8PVEST-MFR ), None (IVESTC8-R8PVEST-MML ), None (IVESTC8-R8PVEST-MMR ), None (IVESTC8-R8PVEST-SFR ), None (IVESTC8-R8PVEST-XSFR ), None (IVESTC8-R8PVEST-2XFR ), None (IVESTC8-R8PVEST-LML ), None (IVESTC8-R8PVEST-LMXL ), None (IVESTC8-R8PVEST-MFS ), None (IVESTC8-R8PVEST-SFL ), None (IVESTC8-R8PVEST-SFS ), None (IVESTC8-R8PVEST-XLFL ), None (IVESTC8-R8PVEST-XLMR ). 5. Model Number: R8QVEST; UDI-DI (Product Code): 00840331260076 (QVESTC18-R8QVEST-LF ), 00840331260083 (QVESTC18-R8QVEST-MF ), None (QVESTC18-R8QVEST-PLUS ), 00840331260106 (QVESTC18-R8QVEST-SF ), 00840331260113 (QVESTC18-R8QVEST-XLF ), 00840331260007 (QVESTC28-R8QVEST-2XF ), 00840331269802 (QVESTT18-R8QVEST-LF ), 00840331269802 (QVESTT18-R8QVEST-MF ), 00840331269802 (QVESTT18-R8QVEST-PLUS ), 00840331269802 (QVESTT18-R8QVEST-SF ), 00840331269802 (QVESTT18-R8QVEST-XLF ), 00840331269802 (QVESTT28-R8QVEST-2XF ), 00840331269802 (QVESTT28-R8QVEST-3XF ), 00840331269802 (QVESTT28-R8QVEST-4XF ), 00840331269802 (QVESTT28-R8QVEST-5XF ), 00840331269802 (QVESTT38-R8QVEST-8XF ), None (IQVESTC8-R8QVEST-SFR ), 00840331260120 (QVESTC18-R8QVEST-XSF ), None (IQVESTC8-R8QVEST-MFR). 6. Model Number: R8VEST; UDI-DI (Product Code): 00840331261752 (VESTC18-R8VEST-2XF ), 00840331261769 (VESTC18-R8VEST-2XM ), 00840331261776 (VESTC18-R8VEST-3XF ), 00840331261783 (VESTC18-R8VEST-3XM ), 00840331261790 (VESTC8-R8VEST-LF ), 00840331261806 (VESTC8-R8VEST-LM ), 00840331261813 (VESTC8-R8VEST-MF ), 00840331261820 (VESTC8-R8VEST-MM ), 00840331261837 (VESTC8-R8VEST-PLUS ), 00840331261844 (VESTC8-R8VEST-SF ), 00840331261851 (VESTC8-R8VEST-SM ), 00840331261868 (VESTC8-R8VEST-XLF ), 00840331261875 (VESTC8-R8VEST-XLM ), 00840331261882 (VESTC8-R8VEST-XSF ), 00840331261899 (VESTC8-R8VEST-XSM ), 00840331261790 (VESTS8-R8VEST-LF ), 00840331261806 (VESTS8-R8VEST-LM ), 00840331261813 (VESTS8-R8VEST-MF ), 00840331261820 (VESTS8-R8VEST-MM ), 00840331261837 (VESTS8-R8VEST-PLUS ), 00840331261844 (VESTS8-R8VEST-SF ), 00840331261851 (VESTS8-R8VEST-SM ), 00840331261868 (VESTS8-R8VEST-XLF ), 00840331261875 (VESTS8-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-LF ), 00840331269635 (VESTT18-R8VEST-LM ), 00840331269628 (VESTT18-R8VEST-MF ), 00840331269635 (VESTT18-R8VEST-MM ), 00840331269628 (VESTT18-R8VEST-PLUS ), 00840331269628 (VESTT18-R8VEST-SF ), 00840331269635 (VESTT18-R8VEST-SM ), 00840331269628 (VESTT18-R8VEST-XLF ), 00840331269635 (VESTT18-R8VEST-XLM ), 00840331269628 (VESTT18-R8VEST-XSF ), 00840331269635 (VESTT18-R8VEST-XSM ), 00840331269628 (VESTT28-R8VEST-2XF ), 00840331269635 (VESTT28-R8VEST-2XM ), 00840331269628 (VESTT28-R8VEST-3XF ), 00840331269635 (VESTT28-R8VEST-3XM ), 00840331269628 (VESTT28-R8VEST-4XF ), 00840331269635 (VESTT28-R8VEST-4XM ), 00840331269628 (VESTT28-R8VEST-5XF ), 00840331269635 (VESTT28-R8VEST-5XM ), 00840331269628 (VESTT38-R8VEST-6XF ), 00840331269635 (VESTT38-R8VEST-6XM ), 00840331269628 (VESTT38-R8VEST-7XF ), 00840331269635 (VESTT38-R8VEST-7XM ), 00840331269628 (VESTT38-R8VEST-8XF ), 00840331269635 (VESTT38-R8VEST-8XM ), None (IVESTC8-R8VEST-LFR ), None (IVESTC8-R8VEST-LMR ), None (IVESTC8-R8VEST-MMR ), None (IVESTC8-R8VEST-SMS ), None (IVESTC8-R8VEST-MFR ), None (IVESTC8-R8VEST-SFR), None (IVESTC8-R8VEST-LML ), None (IVESTC8-R8VEST-SMR ). 7. Model Number: R8ZVEST; UDI-DI (Product Code): 00840331262063 (ZVESTC18-R8ZVEST-LM), 00840331262087 (ZVESTC18-R8ZVEST-MM), 00840331262087 (ZVESTC18-R8ZVEST-SF), 00840331262148 (ZVESTC18-R8ZVEST-XSF), 00840331269840 (ZVESTT18-R8ZVEST-LM), 00840331269833 (ZVESTT18-R8ZVEST-PLUS), 00840331269840 (ZVESTT28-R8ZVEST-2XM), 00840331269833 (ZVESTT28-R8ZVEST-3XF), None (IZVESTC8-R8ZVEST-LFR). 8. Model Number: S8FVEST; UDI-DI (Product Code): 00840331263275 (VESTC18-S8FVEST-2XF ), 00840331263305 (VESTC18-S8FVEST-3XM ), 00840331263312 (VESTC8-S8FVEST-LF ), 00840331263329 (VESTC8-S8FVEST-LM ), 00840331263336 (VESTC8-S8FVEST-MF ), 00840331263343 (VESTC8-S8FVEST-MM ), 00840331263350 (VESTC8-S8FVEST-PLUS ), 00840331263367 (VESTC8-S8FVEST-SF ), 00840331263374 (VESTC8-S8FVEST-SM ), 00840331263381 (VESTC8-S8FVEST-XLF ), 00840331263398 (VESTC8-S8FVEST-XLM ), 00840331269765 (VESTT18-S8FVEST-LF ), 00840331269772 (VESTT18-S8FVEST-LM ), 00840331269765 (VESTT18-S8FVEST-MF ), 00840331269772 (VESTT18-S8FVEST-MM ), 00840331269765 (VESTT18-S8FVEST-PLUS ), 00840331269765 (VESTT18-S8FVEST-SF ), 00840331269772 (VESTT18-S8FVEST-SM ), 00840331269765 (VESTT18-S8FVEST-XLF ), 00840331269772 (VESTT18-S8FVEST-XLM ), 00840331269772 (VESTT28-S8FVEST-2XM ), 00840331269765 (VESTT28-S8FVEST-3XF ), 00840331269772 (VESTT28-S8FVEST-3XM ), 00840331269765 (VESTT28-S8FVEST-4XF ), 00840331269772 (VESTT28-S8FVEST-4XM ), 00840331269765 (VESTT28-S8FVEST-5XF ), 00840331269772 (VESTT28-S8FVEST-5XM ), 00840331269765 (VESTT38-S8FVEST-6XF ), 00840331269772 (VESTT38-S8FVEST-6XM ), 00840331269765 (VESTT38-S8FVEST-7XF ), 00840331269765 (VESTT38-S8FVEST-8XF ). 9. Model Number: S8PVEST; UDI-DI (Product Code): 00840331263596 (VESTC18-S8PVEST-2XF ), 00840331263602 (VESTC18-S8PVEST-2XM ), 00840331263633 (VESTC8-S8PVEST-LF ), 00840331263640 (VESTC8-S8PVEST-LM ), 00840331263657 (VESTC8-S8PVEST-MF ), 00840331263664 (VESTC8-S8PVEST-MM ), 00840331263671 (VESTC8-S8PVEST-PLUS ), 00840331263688 (VESTC8-S8PVEST-SF ), 00840331263695 (VESTC8-S8PVEST-SM ), 00840331263701 (VESTC8-S8PVEST-XLF ), 00840331263718 (VESTC8-S8PVEST-XLM ), 00840331269703 (VESTT18-S8PVEST-LF ), 00840331269710 (VESTT18-S8PVEST-LM ), 00840331269703 (VESTT18-S8PVEST-MF ), 00840331269710 (VESTT18-S8PVEST-MM ), 00840331269703 (VESTT18-S8PVEST-PLUS ), 00840331269703 (VESTT18-S8PVEST-SF ), 00840331269710 (VESTT18-S8PVEST-SM ), 00840331269703 (VESTT18-S8PVEST-XLF ), 00840331269710 (VESTT18-S8PVEST-XLM ), 00840331269710 (VESTT18-S8PVEST-XSM ), 00840331269703 (VESTT28-S8PVEST-2XF ), 00840331269710 (VESTT28-S8PVEST-2XM ), 00840331269703 (VESTT28-S8PVEST-3XF ), 00840331269710 (VESTT28-S8PVEST-3XM ), 00840331269703 (VESTT28-S8PVEST-4XF ), 00840331269710 (VESTT28-S8PVEST-4XM ), 00840331269703 (VESTT28-S8PVEST-5XF ), 00840331269710 (VESTT28-S8PVEST-5XM ), 00840331269703 (VESTT38-S8PVEST-6XF ), 00840331269710 (VESTT38-S8PVEST-6XM ), 00840331269703 (VESTT38-S8PVEST-7XF ), 00840331269710 (VESTT38-S8PVEST-7XM ), 00840331269703 (VESTT38-S8PVEST-8XF ), 00840331269710 (VESTT38-S8PVEST-8XM ). 10. Model Number: S8QVEST; UDI-DI (Product Code): 00840331263794 (QVESTC18-S8QVEST-LF ), 00840331263800 (QVESTC18-S8QVEST-MF ), 00840331263817 (QVESTC18-S8QVEST-PLUS ), 00840331263824 (QVESTC18-S8QVEST-SF ), 00840331263831 (QVESTC18-S8QVEST-XLF ), 00840331269819 (QVESTT18-S8QVEST-LF ), 00840331269819 (QVESTT18-S8QVEST-MF ), 00840331269819 (QVESTT18-S8QVEST-PLUS ), 00840331269819 (QVESTT18-S8QVEST-XLF ), 00840331269819 (QVESTT28-S8QVEST-2XF ), 00840331269819 (QVESTT28-S8QVEST-3XF ), 00840331269819 (QVESTT28-S8QVEST-4XF ), 00840331269819 (QVESTT28-S8QVEST-5XF ), 00840331269819 (QVESTT38-S8QVEST-6XF ), 00840331269819 (QVESTT38-S8QVEST-7XF ). 11. Model Number: S8VEST; UDI-DI (Product Code): 00840331265477 (VESTC18-S8VEST-2XF ), 00840331265484 (VESTC18-S8VEST-2XM ), 00840331265491 (VESTC18-S8VEST-3XF ), 00840331265514 (VESTC8-S8VEST-LF ), 00840331265521 (VESTC8-S8VEST-LM ), 00840331265538 (VESTC8-S8VEST-MF ), 00840331265545 (VESTC8-S8VEST-MM ), 00840331265552 (VESTC8-S8VEST-PLUS ), 00840331265569 (VESTC8-S8VEST-SF ), 00840331265576 (VESTC8-S8VEST-SM ), 00840331265583 (VESTC8-S8VEST-XLF ), 00840331265590 (VESTC8-S8VEST-XLM ), 00840331265606 (VESTC8-S8VEST-XSF ), 00840331265613 (VESTC8-S8VEST-XSM ), 00840331265514 (VESTS8-S8VEST-LF ), 00840331265521 (VESTS8-S8VEST-LM ), 00840331265538 (VESTS8-S8VEST-MF ), 00840331265545 (VESTS8-S8VEST-MM ), 00840331265569 (VESTS8-S8VEST-SF ), 00840331265576 (VESTS8-S8VEST-SM ), 00840331265583 (VESTS8-S8VEST-XLF ), 00840331265590 (VESTS8-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-LF ), 00840331269659 (VESTT18-S8VEST-LM ), 00840331269642 (VESTT18-S8VEST-MF ), 00840331269659 (VESTT18-S8VEST-MM ), 00840331269642 (VESTT18-S8VEST-PLUS ), 00840331269642 (VESTT18-S8VEST-SF ), 00840331269659 (VESTT18-S8VEST-SM ), 00840331269642 (VESTT18-S8VEST-XLF ), 00840331269659 (VESTT18-S8VEST-XLM ), 00840331269642 (VESTT18-S8VEST-XSF ), 00840331269659 (VESTT18-S8VEST-XSM ), 00840331269642 (VESTT28-S8VEST-2XF ), 00840331269659 (VESTT28-S8VEST-2XM ), 00840331269642 (VESTT28-S8VEST-3XF ), 00840331269659 (VESTT28-S8VEST-3XM ), 00840331269642 (VESTT28-S8VEST-4XF ), 00840331269659 (VESTT28-S8VEST-4XM ), 00840331269642 (VESTT28-S8VEST-5XF ), 00840331269659 (VESTT28-S8VEST-5XM ), 00840331269642 (VESTT38-S8VEST-6XF ), 00840331269659 (VESTT38-S8VEST-6XM ), 00840331269642 (VESTT38-S8VEST-7XF ), 00840331269659 (VESTT38-S8VEST-7XM ), 00840331269642 (VESTT38-S8VEST-8XF ), 00840331269659 (VESTT38-S8VEST-8XM ), None (IVESTC8-S8VEST-SMS ), None (IVESTC8-S8VEST-LMR ), None (IVESTC8-S8VEST-MMR ). 12. Model Number: S8ZVEST; UDI-DI (Product Code): 00840331265781 (ZVESTC18-S8ZVEST-LM ), 00840331265804 (ZVESTC18-S8ZVEST-MM ), 00840331269864 (ZVESTT18-S8ZVEST-LF ), 00840331269864 (ZVESTT18-S8ZVEST-PLUS ). 13. Model Number: U8FVEST; UDI-DI (Product Code): 00840331267044 (VESTC8-U8FVEST-LF ), 00840331267051 (VESTC8-U8FVEST-LM ), 00840331267075 (VESTC8-U8FVEST-MM ), 00840331267099 (VESTC8-U8FVEST-SF ), 00840331267105 (VESTC8-U8FVEST-SM ), 00840331267112 (VESTC8-U8FVEST-XLF ), 00840331267136 (VESTC8-U8FVEST-XSF ), 00840331269796 (VESTT18-U8FVEST-LM ), 00840331269789 (VESTT18-U8FVEST-PLUS ), 00840331269789 (VESTT18-U8FVEST-XLF ), 00840331269796 (VESTT28-U8FVEST-2XM ), 00840331269789 (VESTT28-U8FVEST-3XF ), 00840331269796 (VESTT28-U8FVEST-3XM ), 00840331269789 (VESTT38-U8FVEST-6XF ), None (IVESTC8-U8FVEST-LML ), None (IVESTC8-U8FVEST-LMR ), None (IVESTC8-U8FVEST-MFR ), None (IVESTC8-U8FVEST-MMR ), None (IVESTC8-U8FVEST-SFR ), None (IVESTC8-U8FVEST-XLML ), None (IVESTC8-U8FVEST-XLMR ). 14. Model Number: U8PVEST; UDI-DI (Product Code): 00840331267013 (VESTC18-U8PVEST-2XM ), 00840331267365 (VESTC8-U8PVEST-LF ), 00840331267372 (VESTC8-U8PVEST-LM ), 00840331267389 (VESTC8-U8PVEST-MF ), 00840331267396 (VESTC8-U8PVEST-MM ), 00840331267402 (VESTC8-U8PVEST-PLUS ), 00840331267419 (VESTC8-U8PVEST-SF ), 00840331267433 (VESTC8-U8PVEST-XLF ), 00840331267440 (VESTC8-U8PVEST-XLM ), 00840331267464 (VESTC8-U8PVEST-XSM ), 00840331269727 (VESTT18-U8PVEST-LF ), 00840331269734 (VESTT18-U8PVEST-LM ), 00840331269727 (VESTT18-U8PVEST-MF ), 00840331269734 (VESTT18-U8PVEST-MM ), 00840331269727 (VESTT18-U8PVEST-PLUS ), 00840331269727 (VESTT18-U8PVEST-SF ), 00840331269734 (VESTT18-U8PVEST-SM ), 00840331269727 (VESTT18-U8PVEST-XLF ), 00840331269734 (VESTT18-U8PVEST-XLM ), 00840331269734 (VESTT18-U8PVEST-XSM ), 00840331269727 (VESTT28-U8PVEST-2XF ), 00840331269734 (VESTT28-U8PVEST-2XM ), 00840331269727 (VESTT28-U8PVEST-3XF ), 00840331269734 (VESTT28-U8PVEST-3XM ), 00840331269734 (VESTT28-U8PVEST-4XF ), 00840331269727 (VESTT28-U8PVEST-4XF ), 00840331269734 (VESTT28-U8PVEST-4XM ), 00840331269727 (VESTT28-U8PVEST-5XF ), 00840331269734 (VESTT28-U8PVEST-5XM ), 00840331269727 (VESTT38-U8PVEST-6XF ), None (IVESTC8-U8PVEST-2XMR ), None (IVESTC8-U8PVEST-LMR ), None (IVESTC8-U8PVEST-MFR ), None (IVESTC8-U8PVEST-MMR ), None (IVESTC8-U8PVEST-SFR ), None (IVESTC8-U8PVEST-SMR ). 15. Model Number: U8QVEST; UDI-DI (Product Code): 00840331267556 (QVESTC18-U8QVEST-LF ), 00840331267563 (QVESTC18-U8QVEST-MF ), 00840331267594 (QVESTC18-U8QVEST-XLF ), 00840331267525 (QVESTC28-U8QVEST-3XF ), 00840331269826 (QVESTT18-U8QVEST-LF ), 00840331269826 (QVESTT18-U8QVEST-PLUS ), 00840331269826 (QVESTT28-U8QVEST-3XF ), 00840331296136 (QVESTT38-U8QVEST-8XF ), None (IQVESTC8-U8QVEST-LFR ). 16. Model Number: U8VEST; UDI-DI (Product Code): 00840331269215 (VESTC18-U8VEST-2XF ), 00840331269222 (VESTC18-U8VEST-2XM ), 00840331269253 (VESTC8-U8VEST-LF ), 00840331269260 (VESTC8-U8VEST-LM ), 00840331269277 (VESTC8-U8VEST-MF ), 00840331269284 (VESTC8-U8VEST-MM ), 00840331269291 (VESTC8-U8VEST-PLUS ), 00840331269307 (VESTC8-U8VEST-SF ), 00840331269314 (VESTC8-U8VEST-SM ), 00840331269321 (VESTC8-U8VEST-XLF ), 00840331269338 (VESTC8-U8VEST-XLM ), 00840331269352 (VESTC8-U8VEST-XSM ), 00840331269260 (VESTS8-U8VEST-LM ), 00840331269277 (VESTS8-U8VEST-MF ), 00840331269666 (VESTT18-U8VEST-LF ), 00840331269673 (VESTT18-U8VEST-LM ), 00840331269666 (VESTT18-U8VEST-MF ), 00840331269673 (VESTT18-U8VEST-MM ), 00840331269666 (VESTT18-U8VEST-PLUS ), 00840331269666 (VESTT18-U8VEST-SF ), 00840331269673 (VESTT18-U8VEST-SM ), 00840331269666 (VESTT18-U8VEST-XLF ), 00840331269673 (VESTT18-U8VEST-XLM ), 00840331269673 (VESTT18-U8VEST-XSM ), 00840331269666 (VESTT28-U8VEST-2XF ), 00840331269673 (VESTT28-U8VEST-2XM ), 00840331269666 (VESTT28-U8VEST-3XF ), 00840331269673 (VESTT28-U8VEST-3XM ), 00840331269666 (VESTT28-U8VEST-4XF ), 00840331269673 (VESTT28-U8VEST-4XM ), 00840331269666 (VESTT28-U8VEST-5XF ), 00840331269673 (VESTT28-U8VEST-5XM ), 00840331269666 (VESTT38-U8VEST-6XF ), 00840331269673 (VESTT38-U8VEST-6XM ), 00840331269666 (VESTT38-U8VEST-7XF ), 00840331269666 (VESTT38-U8VEST-7XM ), 00840331269666 (VESTT38-U8VEST-8XF ), 00840331269673 (VESTT38-U8VEST-8XM ), None (IVESTC8-U8VEST-2XMR ), None (IVESTC8-U8VEST-LMR ), None (IVESTC8-U8VEST-MMR ), None (IVESTC8-U8VEST-SFR ), None (IVESTC8-U8VEST-SMR ), None (IVESTC8-U8VEST-XLMR ), None (IVESTC8-U8VEST-XSFR ). 17. Model Number: U8ZVEST; UDI-DI (Product Code): 00840331269536 (ZVESTC18-U8ZVEST-MF ), 00840331269543 (ZVESTC18-U8ZVEST-MM ), 00840331269901 (ZVESTT28-U8ZVEST-5XM ).
Burlington Medical, Frontal Aprons
UDI-DI
00840331297706
00840331258400
00840331258417
00840331258448
00840331258455
00840331258462
00840331258479
00840331258486
00840331258493
00840331258509
00840331258516
00840331258523
00840331270341
00840331270358
00840331258578
00840331258608
00840331258615
00840331258622
00840331258639
00840331258646
00840331258653
00840331258660
00840331258677
00840331258684
00840331258691
00840331258707
00840331270280
00840331270297
00840331258899
00840331258929
00840331258936
00840331258943
00840331258950
00840331259001
00840331259360
00840331259377
00840331259384
00840331259391
00840331259407
00840331259414
00840331259421
00840331259438
00840331259445
00840331259452
00840331259469
00840331259476
00840331259483
00840331259490
00840331259506
00840331270228
00840331270235
00197513001287
00197513001270
00840331262179
00840331262209
00840331296174
00840331262216
00840331262223
00840331262230
00840331262247
00840331262254
00840331262261
00840331262278
00840331262285
00840331270365
00840331270372
00840331262315
00840331262322
00840331262339
00840331262353
00840331262360
00840331262377
00840331262384
00840331262391
00840331262407
00840331262414
00840331262421
00840331262438
00840331262445
00840331270303
00840331270310
00840331262674
00840331262698
00840331262704
00840331262728
00840331262742
00840331262759
00840331262766
00840331270433
00840331270426
00840331263114
00840331263121
00840331263138
00840331263145
00840331263152
00840331263169
00840331263176
00840331263183
00840331263190
00840331263206
00840331263213
00840331263220
00840331263237
00840331263244
00840331263251
00840331270242
00840331270259
00840331265927
00840331265934
00840331265941
00840331265958
00840331265972
00840331265989
00840331265996
00840331266009
00840331266023
00840331270389
00840331270396
00840331266054
00840331266085
00840331266092
00840331266108
00840331266115
00840331266122
00840331266139
00840331266146
00840331266160
00840331270327
00840331270334
00840331266450
00840331266856
00840331266863
00840331266870
00840331266887
00840331266894
00840331266900
00840331266917
00840331266924
00840331266931
00840331266948
00840331266955
00840331266962
00840331266979
00840331266986
00840331270266
00840331270273
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8F17; UDI-DI (Product Code): 00840331297706 (FRONTALC18-C8F17-2XM ), 00840331297706 (FRONTALC8-C8F17-LF ), 00840331297706 (FRONTALC8-C8F17-LM ), 00840331297706 (FRONTALC8-C8F17-MF ), 00840331297706 (FRONTALC8-C8F17-MM ), 00840331297706 (FRONTALC8-C8F17-SF ), 00840331297706 (FRONTALC8-C8F17-SM ), 00840331297706 (FRONTALC8-C8F17-XLM ), 00840331297706 (FRONTALC8-C8F17-XSF ), 00840331297706 (FRONTALT18-C8F17-LM ), 00840331297706 (FRONTALT18-C8F17-MM ), 00840331297706 (FRONTALT28-C8F17-3XM ). 2. Model Number: R8601; UDI-DI (Product Code): 00840331258400 (FRONTALC18-R8601-2XF ), 00840331258417 (FRONTALC18-R8601-2XM ), 00840331258448 (FRONTALC8-R8601-LF ), 00840331258455 (FRONTALC8-R8601-LM ), 00840331258462 (FRONTALC8-R8601-MF ), 00840331258479 (FRONTALC8-R8601-MM ), 00840331258486 (FRONTALC8-R8601-PLUS ), 00840331258493 (FRONTALC8-R8601-SF ), 00840331258509 (FRONTALC8-R8601-SM ), 00840331258516 (FRONTALC8-R8601-XLF ), 00840331258523 (FRONTALC8-R8601-XLM ), 00840331270341 (FRONTALT18-R8601-LF ), 00840331270358 (FRONTALT18-R8601-LM ), 00840331270341 (FRONTALT18-R8601-MF ), 00840331270358 (FRONTALT18-R8601-MM ), 00840331270341 (FRONTALT18-R8601-PLUS ), 00840331270341 (FRONTALT18-R8601-SF ), 00840331270358 (FRONTALT18-R8601-SM ), 00840331270358 (FRONTALT18-R8601-XLM ), 00840331270341 (FRONTALT28-R8601-2XF ), 00840331270358 (FRONTALT28-R8601-2XM ), 00840331270358 (FRONTALT28-R8601-3XM ), 00840331270358 (FRONTALT28-R8601-4XM ), None (IFRONTALC8-R8601-2XMR ), None (IFRONTALC8-R8601-LMR ), None (IFRONTALC8-R8601-MFR ), None (IFRONTALC8-R8601-MMR ), None (IFRONTALC8-R8601-SFR ), None (IFRONTALC8-R8601-SMR ), None (IFRONTALC8-R8601-XLMR ), None (IFRONTALC8-R8601-XSFR ), None (IFRONTALC8-R8601-XSMR ), None (IFRONTALC8-R8601-LML ). 3. Model Number: R8A10; UDI-DI (Product Code): 00840331258578 (FRONTALC18-R8A10-2XM ), 00840331258608 (FRONTALC8-R8A10-LF ), 00840331258615 (FRONTALC8-R8A10-LM ), 00840331258622 (FRONTALC8-R8A10-MF ), 00840331258639 (FRONTALC8-R8A10-MM ), 00840331258646 (FRONTALC8-R8A10-PLUS ), 00840331258653 (FRONTALC8-R8A10-SF ), 00840331258660 (FRONTALC8-R8A10-SM ), 00840331258677 (FRONTALC8-R8A10-XLF ), 00840331258684 (FRONTALC8-R8A10-XLM ), 00840331258691 (FRONTALC8-R8A10-XSF ), 00840331258707 (FRONTALC8-R8A10-XSM ), 00840331270280 (FRONTALT18-R8A10-LF ), 00840331270297 (FRONTALT18-R8A10-LM ), 00840331270280 (FRONTALT18-R8A10-MF ), 00840331270297 (FRONTALT18-R8A10-MM ), 00840331270280 (FRONTALT18-R8A10-PLUS ), 00840331270280 (FRONTALT18-R8A10-SF ), 00840331270297 (FRONTALT18-R8A10-SM ), 00840331270297 (FRONTALT18-R8A10-XLM ), 00840331270297 (FRONTALT28-R8A10-2XM ), 00840331270297 (FRONTALT28-R8A10-3XM ), 00840331270297 (FRONTALT28-R8A10-4XM ), 00840331270297 (FRONTALT28-R8A10-5XM ), None (IFRONTALC8-R8A10-LMR ), None (IFRONTALC8-R8A10-MFR ), None (IFRONTALC8-R8A10-MMR ), None (IFRONTALC8-R8A10-XLMR ). 4. Model Number: R8F01; UDI-DI (Product Code): 00840331258899 (FRONTALC18-R8F01-2XM ), 00840331258929 (FRONTALC8-R8F01-LF ), 00840331258936 (FRONTALC8-R8F01-LM ), 00840331258943 (FRONTALC8-R8F01-MF ), 00840331258950 (FRONTALC8-R8F01-MM ), 00840331258936 (FRONTALS8-R8F01-LM ), 00840331258943 (FRONTALS8-R8F01-MF ), 00840331259001 (FRONTALS8-R8F01-XLM ). 5. Model Number: R8F17; UDI-DI (Product Code): 00840331259360 (FRONTALC18-R8F17-2XF ), 00840331259377 (FRONTALC18-R8F17-2XM ), 00840331259384 (FRONTALC18-R8F17-3XF ), 00840331259391 (FRONTALC18-R8F17-3XM ), 00840331259407 (FRONTALC8-R8F17-LF ), 00840331259414 (FRONTALC8-R8F17-LM ), 00840331259421 (FRONTALC8-R8F17-MF ), 00840331259438 (FRONTALC8-R8F17-MM ), 00840331259445 (FRONTALC8-R8F17-PLUS ), 00840331259452 (FRONTALC8-R8F17-SF ), 00840331259469 (FRONTALC8-R8F17-SM ), 00840331259476 (FRONTALC8-R8F17-XLF ), 00840331259483 (FRONTALC8-R8F17-XLM ), 00840331259490 (FRONTALC8-R8F17-XSF ), 00840331259506 (FRONTALC8-R8F17-XSM ), 00840331259407 (FRONTALS8-R8F17-LF ), 00840331259414 (FRONTALS8-R8F17-LM ), 00840331259414 (FRONTALS8-R8F17-MF ), 00840331259438 (FRONTALS8-R8F17-MM ), 00840331259452 (FRONTALS8-R8F17-SF ), 00840331259469 (FRONTALS8-R8F17-SM ), 00840331259476 (FRONTALS8-R8F17-XLF ), 00840331259483 (FRONTALS8-R8F17-XLM ), 00840331259506 (FRONTALS8-R8F17-XSM ), 00840331270228 (FRONTALT18-R8F17-LF ), 00840331270235 (FRONTALT18-R8F17-LM ), 00840331270228 (FRONTALT18-R8F17-MF ), 00840331270235 (FRONTALT18-R8F17-MM ), 00840331270228 (FRONTALT18-R8F17-PLUS ), 00840331270228 (FRONTALT18-R8F17-SF ), 00840331270235 (FRONTALT18-R8F17-SM ), 00840331270228 (FRONTALT18-R8F17-XLF ), 00840331270235 (FRONTALT18-R8F17-XLM ), 00840331270228 (FRONTALT18-R8F17-XSF ), 00840331270235 (FRONTALT18-R8F17-XSM ), 00840331270228 (FRONTALT28-R8F17-2XF ), 00840331270235 (FRONTALT28-R8F17-2XM ), 00840331270228 (FRONTALT28-R8F17-3XF ), 00840331270235 (FRONTALT28-R8F17-3XM ), 00840331270228 (FRONTALT28-R8F17-4XF ), 00840331270235 (FRONTALT28-R8F17-4XM ), 00840331270228 (FRONTALT28-R8F17-5XF ), None (IFRONTALC8-R8F17-LML ), None (IFRONTALC8-R8F17-MMR ), None (IFRONTALC8-R8F17-XLMXL ), None (IFRONTALC8-R8F17-MFR ), None (IFRONTALC8-R8F17-MML ), None (IFRONTALC8-R8F17-SMR ), None (IFRONTALC8-R8F17-PLUSL ), None (IFRONTALC8-R8F17-SFR ), None (IFRONTALC8-R8F17-LFR ), None (IFRONTALC8-R8F17-MFS ), None (IFRONTALC8-R8F17-SML ), None (IFRONTALC8-R8F17-LMR ). 6. Model Number: R8P500; UDI-DI (Product Code): 00197513001287 (PFRONTALC8-R8P500-LG ), 00197513001270 (PFRONTALC8-R8P500-MD ). 7. Model Number: S8601; UDI-DI (Product Code): 00840331262179 (FRONTALC18-S8601-2XM ), 00840331262209 (FRONTALC8-S8601-LF ), 00840331296174 (FRONTALC8-S8601-LM ), 00840331262216 (FRONTALC8-S8601-MF ), 00840331262223 (FRONTALC8-S8601-MM ), 00840331262230 (FRONTALC8-S8601-PLUS ), 00840331262247 (FRONTALC8-S8601-SF ), 00840331262254 (FRONTALC8-S8601-SM ), 00840331262261 (FRONTALC8-S8601-XLF ), 00840331262278 (FRONTALC8-S8601-XLM ), 00840331262285 (FRONTALC8-S8601-XSF ), 00840331270365 (FRONTALT18-S8601-LF ), 00840331270372 (FRONTALT18-S8601-LM ), 00840331270365 (FRONTALT18-S8601-MF ), 00840331270372 (FRONTALT18-S8601-MM ), 00840331270365 (FRONTALT18-S8601-PLUS ), 00840331270372 (FRONTALT18-S8601-SM ), 00840331270372 (FRONTALT18-S8601-XLF ), 00840331270372 (FRONTALT18-S8601-XLM ), 00840331270372 (FRONTALT28-S8601-2XM ), 00840331270372 (FRONTALT28-S8601-3XM ), 00840331270372 (FRONTALT28-S8601-4XM ), None (IFRONTALC8-S8601-PLUSL ). 8. Model Number: S8A10; UDI-DI (Product Code): 00840331262315 (FRONTALC18-S8A10-2XF ), 00840331262322 (FRONTALC18-S8A10-2XM ), 00840331262339 (FRONTALC18-S8A10-3XF ), 00840331262353 (FRONTALC8-S8A10-LF ), 00840331262360 (FRONTALC8-S8A10-LM ), 00840331262377 (FRONTALC8-S8A10-MF ), 00840331262384 (FRONTALC8-S8A10-MM ), 00840331262391 (FRONTALC8-S8A10-PLUS ), 00840331262407 (FRONTALC8-S8A10-SF ), 00840331262414 (FRONTALC8-S8A10-SM ), 00840331262421 (FRONTALC8-S8A10-XLF ), 00840331262438 (FRONTALC8-S8A10-XLM ), 00840331262445 (FRONTALC8-S8A10-XSF ), 00840331270303 (FRONTALT18-S8A10-LF ), 00840331270310 (FRONTALT18-S8A10-LM ), 00840331270303 (FRONTALT18-S8A10-MF ), 00840331270310 (FRONTALT18-S8A10-MM ), 00840331270303 (FRONTALT18-S8A10-PLUS ), 00840331270303 (FRONTALT18-S8A10-SF ), 00840331270310 (FRONTALT18-S8A10-SM ), 00840331270303 (FRONTALT18-S8A10-XLF ), 00840331270310 (FRONTALT18-S8A10-XLM ), 00840331270310 (FRONTALT28-S8A10-2XM ), 00840331270303 (FRONTALT28-S8A10-3XF ), 00840331270310 (FRONTALT28-S8A10-4XM ), 00840331270303 (FRONTALT28-S8A10-5XF ). 9. Model Number: S8F01; UDI-DI (Product Code): 00840331262674 (FRONTALC8-S8F01-LF ), 00840331262698 (FRONTALC8-S8F01-MF ), 00840331262704 (FRONTALC8-S8F01-MM ), 00840331262728 (FRONTALC8-S8F01-SF ), 00840331262742 (FRONTALC8-S8F01-XLF ), 00840331262759 (FRONTALC8-S8F01-XLM ), 00840331262766 (FRONTALC8-S8F01-XSF ), 00840331270433 (FRONTALT18-S8F01-MM ), 00840331270426 (FRONTALT18-S8F01-PLUS ). 10. Model Number: S8F17; UDI-DI (Product Code): 00840331263114 (FRONTALC18-S8F17-2XF ), 00840331263121 (FRONTALC18-S8F17-2XM ), 00840331263138 (FRONTALC18-S8F17-3XF ), 00840331263145 (FRONTALC18-S8F17-3XM ), 00840331263152 (FRONTALC8-S8F17-LF ), 00840331263169 (FRONTALC8-S8F17-LM ), 00840331263176 (FRONTALC8-S8F17-MF ), 00840331263183 (FRONTALC8-S8F17-MM ), 00840331263190 (FRONTALC8-S8F17-PLUS ), 00840331263206 (FRONTALC8-S8F17-SF ), 00840331263213 (FRONTALC8-S8F17-SM ), 00840331263220 (FRONTALC8-S8F17-XLF ), 00840331263237 (FRONTALC8-S8F17-XLM ), 00840331263244 (FRONTALC8-S8F17-XSF ), 00840331263251 (FRONTALC8-S8F17-XSM ), 00840331263152 (FRONTALS8-S8F17-LF ), 00840331263169 (FRONTALS8-S8F17-LM ), 00840331263176 (FRONTALS8-S8F17-MF ), 00840331263183 (FRONTALS8-S8F17-MM ), 00840331263190 (FRONTALS8-S8F17-PLUS ), 00840331263206 (FRONTALS8-S8F17-SF ), 00840331263213 (FRONTALS8-S8F17-SM ), 00840331263220 (FRONTALS8-S8F17-XLF ), 00840331263237 (FRONTALS8-S8F17-XLM ), 00840331263244 (FRONTALS8-S8F17-XSF ), 00840331263251 (FRONTALS8-S8F17-XSM ), 00840331270242 (FRONTALT18-S8F17-LF ), 00840331270259 (FRONTALT18-S8F17-LM ), 00840331270242 (FRONTALT18-S8F17-MF ), 00840331270259 (FRONTALT18-S8F17-MM ), 00840331270242 (FRONTALT18-S8F17-PLUS ), 00840331270242 (FRONTALT18-S8F17-SF ), 00840331270259 (FRONTALT18-S8F17-SM ), 00840331270242 (FRONTALT18-S8F17-XLF ), 00840331270259 (FRONTALT18-S8F17-XLM ), 00840331270242 (FRONTALT18-S8F17-XSF ), 00840331270259 (FRONTALT18-S8F17-XSM ), 00840331270242 (FRONTALT28-S8F17-2XF ), 00840331270259 (FRONTALT28-S8F17-2XM ), 00840331270242 (FRONTALT28-S8F17-3XF ), 00840331270259 (FRONTALT28-S8F17-3XM ), 00840331270242 (FRONTALT28-S8F17-4XF ), 00840331270259 (FRONTALT28-S8F17-4XM ), 00840331270242 (FRONTALT28-S8F17-5XF ), 00840331270259 (FRONTALT28-S8F17-5XM ). 11. Model Number: U8601; UDI-DI (Product Code): 00840331265927 (FRONTALC8-U8601-LF ), 00840331265934 (FRONTALC8-U8601-LM ), 00840331265941 (FRONTALC8-U8601-MF ), 00840331265958 (FRONTALC8-U8601-MM ), 00840331265972 (FRONTALC8-U8601-SF ), 00840331265989 (FRONTALC8-U8601-SM ), 00840331265996 (FRONTALC8-U8601-XLF ), 00840331266009 (FRONTALC8-U8601-XLM ), 00840331266023 (FRONTALC8-U8601-XSM ), 00840331270389 (FRONTALT18-U8601-LF ), 00840331270396 (FRONTALT18-U8601-LM ), 00840331270389 (FRONTALT18-U8601-MF ), 00840331270396 (FRONTALT18-U8601-MM ), 00840331270389 (FRONTALT18-U8601-PLUS ), 00840331270389 (FRONTALT18-U8601-XLF ), 00840331270396 (FRONTALT18-U8601-XLM ), 00840331270396 (FRONTALT28-U8601-2XM ), None (IFRONTALC8-U8601-LML ). 12. Model Number: U8A10; UDI-DI (Product Code): 00840331266054 (FRONTALC18-U8A10-2XM ), 00840331266085 (FRONTALC8-U8A10-LF ), 00840331266092 (FRONTALC8-U8A10-LM ), 00840331266108 (FRONTALC8-U8A10-MF ), 00840331266115 (FRONTALC8-U8A10-MM ), 00840331266122 (FRONTALC8-U8A10-PLUS ), 00840331266139 (FRONTALC8-U8A10-SF ), 00840331266146 (FRONTALC8-U8A10-SM ), 00840331266160 (FRONTALC8-U8A10-XLM ), 00840331270327 (FRONTALT18-U8A10-LF ), 00840331270334 (FRONTALT18-U8A10-LM ), 00840331270334 (FRONTALT18-U8A10-MM ), 00840331270334 (FRONTALT18-U8A10-PLUS ), 00840331270334 (FRONTALT18-U8A10-XLM ), 00840331270327 (FRONTALT28-U8A10-2XF ). 13. Model Number: U8F01; UDI-DI (Product Code): 00840331266450 (FRONTALC8-U8F01-SF ), 14. Model Number: U8F17; UDI-DI (Product Code): 00840331266856 (FRONTALC18-U8F17-2XM ), 00840331266863 (FRONTALC18-U8F17-3XF ), 00840331266870 (FRONTALC18-U8F17-3XM ), 00840331266887 (FRONTALC8-U8F17-LF ), 00840331266894 (FRONTALC8-U8F17-LM ), 00840331266900 (FRONTALC8-U8F17-MF ), 00840331266917 (FRONTALC8-U8F17-MM ), 00840331266924 (FRONTALC8-U8F17-PLUS ), 00840331266931 (FRONTALC8-U8F17-SF ), 00840331266948 (FRONTALC8-U8F17-SM ), 00840331266955 (FRONTALC8-U8F17-XLF ), 00840331266962 (FRONTALC8-U8F17-XLM ), 00840331266979 (FRONTALC8-U8F17-XSF ), 00840331266979 (FRONTALC8-U8F17-XSM ), 00840331266894 (FRONTALS8-U8F17-LM ), 00840331266900 (FRONTALS8-U8F17-MF ), 00840331266917 (FRONTALS8-U8F17-MM ), 00840331266931 (FRONTALS8-U8F17-SF ), 00840331266948 (FRONTALS8-U8F17-SM ), 00840331266962 (FRONTALS8-U8F17-XLM ), 00840331266986 (FRONTALS8-U8F17-XSM ), 00840331270266 (FRONTALT18-U8F17-LF ), 00840331270273 (FRONTALT18-U8F17-LM ), 00840331270266 (FRONTALT18-U8F17-MF ), 00840331270273 (FRONTALT18-U8F17-MM ), 00840331270266 (FRONTALT18-U8F17-PLUS ), 00840331270266 (FRONTALT18-U8F17-SF ), 00840331270273 (FRONTALT18-U8F17-SM ), 00840331270266 (FRONTALT18-U8F17-XLF ), 00840331270273 (FRONTALT18-U8F17-XLM ), 00840331270273 (FRONTALT18-U8F17-XSM ), 00840331270266 (FRONTALT28-U8F17-2XF ), 00840331270273 (FRONTALT28-U8F17-2XM ), 00840331270266 (FRONTALT28-U8F17-3XF ), 00840331270273 (FRONTALT28-U8F17-3XM ), 00840331270266 (FRONTALT28-U8F17-4XF ), 00840331270273 (FRONTALT28-U8F17-4XM ), None (IFRONTALC8-U8F17-2XMR ), None (IFRONTALC8-U8F17-LMR ), None (IFRONTALC8-U8F17-MMR ).
Burlington Medical, Protective Sleeves.
UDI-DI
00840331271904
00840331271911
00840331271928
00840331271935
00840186699816
00840331271942
00840331271959
00840331271966
00840331271973
00840331271980
00840186699823
00840331271997
00840331272000
00840331272017
00840331272024
00840331272031
00840186699830
00840331272048
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).
Burlington Medical, Blockers.
UDI-DI
00840331272895
00840331272901
00840331272918
00840331272932
00840331272949
00840331272956
00840331272963
00840331272970
00840331272987
00840331273038
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8BLOCKER1; UDI-DI (Product Code): 00840331272895 (BLOCKER8-R8BLOCKER1). 2. Model Number: R8BLOCKER2; UDI-DI (Product Code): 00840331272901 (BLOCKER8-R8BLOCKER2). 3. Model Number: R8BLOCKER3; UDI-DI (Product Code): 00840331272918 (BLOCKER8-R8BLOCKER3). 4. Model Number: R8BLOCKER4; UDI-DI (Product Code): 00840331272932 (BLOCKER8-R8BLOCKER4). 5. Model Number: R8BLOCKER5; UDI-DI (Product Code): 00840331272949 (BLOCKER8-R8BLOCKER5). 6. Model Number: R8BLOCKER6; UDI-DI (Product Code): 00840331272956 (BLOCKER8-R8BLOCKER6). 7. Model Number: S8BLOCKER1; UDI-DI (Product Code): 00840331272963 (BLOCKER8-S8BLOCKER1). 8. Model Number: S8BLOCKER2; UDI-DI (Product Code): 00840331272970 (BLOCKER8-S8BLOCKER2). 9. Model Number: S8BLOCKER3; UDI-DI (Product Code): 00840331272987 (BLOCKER8-S8BLOCKER3). 10. Model Number: U8BLOCKER1; UDI-DI (Product Code): 00840331273038 (BLOCKER8-U8BLOCKER1).
Burlington Medical, Thyroid Shield.
UDI-DI
00840331299052
00840331260311
00840331260328
00840331260359
00840331260366
00840331260373
00840331260397
00840331260403
00840331295948
00840331295955
00840331260427
00840331260434
00840331260465
00840331260458
00840331260441
00840331260489
00840331260496
00840331295979
00840331295986
00840331260519
00840331260533
00840331260540
00840331260557
00840331260571
00840331270525
00840331270532
00840331270549
00840331260595
00840331260601
00840331260618
00840331260625
00840331260632
00840331260649
00840331270594
00840331270587
00840331260656
00840331260663
00840331260670
00840331270495
00840331270501
00840331270518
00840331260687
00840331260694
00840331260700
00840331260717
00840331260724
00840331260731
00840331270563
00840331270556
00840331260748
00840331260755
00840331260762
00840331270464
00840331270471
00840331270488
00840331260786
00840331260793
00840331260809
00840331260816
00840331260823
00840331260830
00840331260847
00840331260854
00840331260861
00840331260878
00840331271430
00840331260892
00840331260922
00840331260939
00840331261011
00840331261028
00840331261035
00840331261080
00840331261097
00840331261103
00840331261110
00840331261141
00840331270976
00840331270983
00840331270990
00840331261165
00840331261172
00840331261189
00840331261196
00840331261202
00840331271041
00840331271034
00840331261226
00840331270952
00840331270969
00840331261257
00840331261264
00840331261271
00840331261288
00840331261295
00840331271010
00840331271003
00840331261318
00840331261325
00840331270921
00840331270938
00840331261349
00840331261356
00840331261363
00840331261370
00840331261387
00840331261400
00840331261417
00840331261431
00840331261462
00840331261479
00840331261547
00840331261554
00840331261561
00840331261622
00840331261646
00840331261653
00840331261660
00840331261677
00840331261684
00840331261738
00840331261745
00840331296006
00840331264197
00840331264265
00840331264272
00840331270693
00840331264326
00840331264340
00840331264357
00840331264364
00840331264388
00840331264395
00840331264401
00840331264418
00840331264432
00840331264449
00840331264456
00840331264470
00840331270617
00840331264517
00840331264524
00840331264531
00840331264548
00840331264555
00840331264562
00840331264579
00840331264586
00840331264593
00840331264807
00840331264784
00840331264883
00840331264906
00840331264913
00840331264920
00840331264944
00840331264999
00840331265002
00840331265019
00840331271164
00840331265033
00840331265064
00840331265088
00840331265095
00840331265101
00840331265118
00840331265132
00840331271799
00840331265187
00840331265279
00840331265286
00840331265392
00840331265408
00840331267853
00840331267990
00840331268010
00840331268027
00840331268089
00840331268102
00840331268119
00840331268126
00840331268140
00840331268201
00840331268218
00840331268294
00840331268300
00840331268324
00840331268331
00840331268560
00840331268621
00840331268652
00840331268713
00840331268737
00840331268744
00840331268829
00840331268836
00840331268843
00840331268867
00840331268874
00840331269130
00840331269147
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8COPEH; UDI-DI (Product Code): 00840331299052 (COPE-R8COPEH-LG). 2. Model Number: R8TSBBB; UDI-DI (Product Code): 00840331260311 (THYROIDSHIELDO8-R8TSBBB-SM). 3. Model Number: R8TSBBN; UDI-DI: 00840331260328; Product Codes: THYROIDSHIELDO8-R8TSBBN-LG, THYROIDSHIELDO8-R8TSBBN-MD, THYROIDSHIELDO8-R8TSBBN-SM. 4. Model Number: R8TSBBR; UDI-DI (Product Code): 00840331260359 (THYROIDSHIELDO8-R8TSBBR-LG), 00840331260366 (THYROIDSHIELDO8-R8TSBBR-MD), 00840331260373 (THYROIDSHIELDO8-R8TSBBR-SM). 5. Model Number: R8TSBBT; UDI-DI (Product Code): 00840331260397 (THYROIDSHIELDO8-R8TSBBT-MD), 00840331260403 (THYROIDSHIELDO8-R8TSBBT-SM). 6. Model Number: R8TSBHB; UDI-DI (Product Code): 00840331295948 (THYROIDSHIELDO8-R8TSBHB-MD), 00840331295955 (THYROIDSHIELDO8-R8TSBHB-SM). 7. Model Number: R8TSBHN; UDI-DI (Product Code): 00840331260427 (THYROIDSHIELDO8-R8TSBHN-MD ), 00840331260434 (THYROIDSHIELDO8-R8TSBHN-SM ). 8. Model Number: R8TSBHR; UDI-DI (Product Code): 00840331260465 (THYROIDSHIELDO8-R8TSBHR-SM ), 00840331260458 (THYROIDSHIELDO8-R8TSBHR-MD ), 00840331260441 (THYROIDSHIELDO8-R8TSBHR-LG ). 9. Model Number: R8TSBHT; UDI-DI (Product Code): 00840331260489 (THYROIDSHIELDO8-R8TSBHT-MD ), 00840331260496 (THYROIDSHIELDO8-R8TSBHT-SM ). 10. Model Number: R8TSBMB; UDI-DI (Product Code): 00840331295979 (THYROIDSHIELDOM8-R8TSBMB-MD ), 00840331295986 (THYROIDSHIELDOM8-R8TSBMB-SM ). 11. Model Number: R8TSBMN; UDI-DI (Product Code): 00840331260519 (THYROIDSHIELDOM8-R8TSBMN-MD ). 12. Model Number: R8TSBMR; UDI-DI (Product Code): 00840331260533 (THYROIDSHIELDOM8-R8TSBMR-LG ), 00840331260540 (THYROIDSHIELDOM8-R8TSBMR-MD ), 00840331260557 (THYROIDSHIELDOM8-R8TSBMR-SM ). 13. Model Number: R8TSBMT; UDI-DI (Product Code): 00840331260571 (THYROIDSHIELDOM8-R8TSBMT-MD ). 14. Model Number: R8TSCBB; UDI-DI (Product Code): 00840331270525 (THYROIDSHIELD8-R8TSCBB-LG ), 00840331270532 (THYROIDSHIELD8-R8TSCBB-MD ), 00840331270549 (THYROIDSHIELD8-R8TSCBB-SM ). 15. Model Number: R8TSCBN; UDI-DI (Product Code): 00840331260595 (THYROIDSHIELD8-R8TSCBN-LG ), 00840331260601 (THYROIDSHIELD8-R8TSCBN-MD ), 00840331260618 (THYROIDSHIELD8-R8TSCBN-SM ). 16. Model Number: R8TSCBR; UDI-DI (Product Code): 00840331260625 (THYROIDSHIELD8-R8TSCBR-LG ), 00840331260632 (THYROIDSHIELD8-R8TSCBR-MD ), 00840331260649 (THYROIDSHIELD8-R8TSCBR-SM ). 17. Model Number: R8TSCBS; UDI-DI (Product Code): 00840331270594 (THYROIDSHIELD8-R8TSCBS-MD ), 00840331270587 (THYROIDSHIELD8-R8TSCBS-SM ). 18. Model Number: R8TSCBT; UDI-DI (Product Code): 00840331260656 (THYROIDSHIELD8-R8TSCBT-LG ), 00840331260663 (THYROIDSHIELD8-R8TSCBT-MD ), 00840331260670 (THYROIDSHIELD8-R8TSCBT-SM ). 19. Model Number: R8TSCHB; UDI-DI (Product Code): 00840331270495 (THYROIDSHIELD8-R8TSCHB-LG ), 00840331270501 (THYROIDSHIELD8-R8TSCHB-MD ), 00840331270518 (THYROIDSHIELD8-R8TSCHB-SM ). 20. Model Number: R8TSCHN; UDI-DI (Product Code): 00840331260687 (THYROIDSHIELD8-R8TSCHN-LG ), 00840331260694 (THYROIDSHIELD8-R8TSCHN-MD ), 00840331260700 (THYROIDSHIELD8-R8TSCHN-SM ). 21. Model Number: R8TSCHR; UDI-DI (Product Code): 00840331260717 (THYROIDSHIELD8-R8TSCHR-LG ), 00840331260724 (THYROIDSHIELD8-R8TSCHR-MD ), 00840331260731 (THYROIDSHIELD8-R8TSCHR-SM ). 22. Model Number: R8TSCHS; UDI-DI (Product Code): 00840331270563 (THYROIDSHIELD8-R8TSCHS-MD ), 00840331270556 (THYROIDSHIELD8-R8TSCHS-SM ). 23. Model Number: R8TSCHT; UDI-DI (Product Code): 00840331260748 (THYROIDSHIELD8-R8TSCHT-LG ), 00840331260755 (THYROIDSHIELD8-R8TSCHT-MD ), 00840331260762 (THYROIDSHIELD8-R8TSCHT-SM ). 24. Model Number: R8TSCMB; UDI-DI (Product Code): 00840331270464 (THYROIDSHIELDM8-R8TSCMB-LG ), 00840331270471 (THYROIDSHIELDM8-R8TSCMB-MD ), 00840331270488 (THYROIDSHIELDM8-R8TSCMB-SM ). 25. Model Number: R8TSCMN; UDI-DI (Product Code): 00840331260786 (THYROIDSHIELDM8-R8TSCMN-MD ), 00840331260793 (THYROIDSHIELDM8-R8TSCMN-SM ). 26. Model Number: R8TSCMR; UDI-DI (Product Code): 00840331260809 (THYROIDSHIELDM8-R8TSCMR-LG ), 00840331260816 (THYROIDSHIELDM8-R8TSCMR-MD ), 00840331260823 (THYROIDSHIELDM8-R8TSCMR-SM ). 27. Model Number: R8TSCMS; UDI-DI (Product Code): 00840331260830 (THYROIDSHIELDM8-R8TSCMS-MD ), 00840331260847 (THYROIDSHIELDM8-R8TSCMS-SM ). 28. Model Number: R8TSCMT; UDI-DI (Product Code): 00840331260854 (THYROIDSHIELDM8-R8TSCMT-LG ), 00840331260861 (THYROIDSHIELDM8-R8TSCMT-MD ), 00840331260878 (THYROIDSHIELDM8-R8TSCMT-SM ). 29. Model Number: R8TSOBB; UDI-DI (Product Code): 00840331271430 (THYROIDSHIELDO8-R8TSOBB-MD ). 30. Model Number: R8TSOBN; UDI-DI (Product Code): 00840331260892 (THYROIDSHIELDO8-R8TSOBN-MD ). 31. Model Number: R8TSOBR; UDI-DI (Product Code): 00840331260922 (THYROIDSHIELDO8-R8TSOBR-MD ), 00840331260939 (THYROIDSHIELDO8-R8TSOBR-SM ). 32. Model Number: R8TSOHB; UDI-DI (Product Code): 00840331260939 (THYROIDSHIELDO8-R8TSOHB-MD, THYROIDSHIELDO8-R8TSOHB-SM ). 33. Model Number: R8TSOHR; UDI-DI (Product Code): 00840331261011 (THYROIDSHIELDO8-R8TSOHR-MD ), 00840331261028 (THYROIDSHIELDO8-R8TSOHR-SM ). 34. Model Number: R8TSOHT; UDI-DI (Product Code): 00840331261035 (THYROIDSHIELDO8-R8TSOHT-LG ). 35. Model Number: R8TSOMN; UDI-DI (Product Code): 00840331261080 (THYROIDSHIELDOM8-R8TSOMN-SM ). 36. Model Number: R8TSOMR; UDI-DI (Product Code): 00840331261097 (THYROIDSHIELDOM8-R8TSOMR-LG ), 00840331261103 (THYROIDSHIELDOM8-R8TSOMR-MD ), 00840331261110 (THYROIDSHIELDOM8-R8TSOMR-SM ). 37. Model Number: R8TSOMT; UDI-DI (Product Code): 00840331261141 (THYROIDSHIELDOM8-R8TSOMT-SM ). 38. Model Number: R8TSSBB; UDI-DI (Product Code): 00840331270976 (THYROIDSHIELD8-R8TSSBB-LG ), 00840331270983 (THYROIDSHIELD8-R8TSSBB-MD ), 00840331270990 (THYROIDSHIELD8-R8TSSBB-SM ). 39. Model Number: R8TSSBN ; UDI-DI (Product Code): 00840331261165 (THYROIDSHIELD8-R8TSSBN-MD ), 00840331261172 (THYROIDSHIELD8-R8TSSBN-SM ), None (THYROIDSHIELDP8-R8TSSBN-PD ). 40. Model Number: R8TSSBR; UDI-DI (Product Code): 00840331261189 (THYROIDSHIELD8-R8TSSBR-LG ), 00840331261196 (THYROIDSHIELD8-R8TSSBR-MD ), 00840331261202 (THYROIDSHIELD8-R8TSSBR-SM ). 41. Model Number: R8TSSBS; UDI-DI (Product Code): 00840331271041 (THYROIDSHIELD8-R8TSSBS-MD ), 00840331271034 (THYROIDSHIELD8-R8TSSBS-SM ). 42. Model Number: R8TSSBT; UDI-DI (Product Code): 00840331261226 (THYROIDSHIELD8-R8TSSBT-MD ). 43. Model Number: R8TSSHB; UDI-DI (Product Code): 00840331270952 (THYROIDSHIELD8-R8TSSHB-MD ), 00840331270969 (THYROIDSHIELD8-R8TSSHB-SM ). 44. Model Number: R8TSSHN; UDI-DI (Product Code): 00840331261257 (THYROIDSHIELD8-R8TSSHN-MD ), 00840331261264 (THYROIDSHIELD8-R8TSSHN-SM ). 45. Model Number: R8TSSHR; UDI-DI (Product Code): 00840331261271 (THYROIDSHIELD8-R8TSSHR-LG ), 00840331261288 (THYROIDSHIELD8-R8TSSHR-MD ), 00840331261295 (THYROIDSHIELD8-R8TSSHR-SM ). 46. Model Number: R8TSSHS; UDI-DI (Product Code): 00840331271010 (THYROIDSHIELD8-R8TSSHS-MD ), 00840331271003 (THYROIDSHIELD8-R8TSSHS-SM ). 47. Model Number: R8TSSHT; UDI-DI (Product Code): 00840331261318 (THYROIDSHIELD8-R8TSSHT-MD ), 00840331261325 (THYROIDSHIELD8-R8TSSHT-SM ). 48. Model Number: R8TSSMB; UDI-DI (Product Code): 00840331270921 (THYROIDSHIELDM8-R8TSSMB-MD ), 00840331270938 (THYROIDSHIELDM8-R8TSSMB-SM ). 49. Model Number: R8TSSMN; UDI-DI (Product Code): 00840331261349 (THYROIDSHIELDM8-R8TSSMN-MD ), 00840331261356 (THYROIDSHIELDM8-R8TSSMN-SM ). 50. Model Number: R8TSSMR; UDI-DI (Product Code): 00840331261363 (THYROIDSHIELDM8-R8TSSMR-LG ), 00840331261370 (THYROIDSHIELDM8-R8TSSMR-MD ), 00840331261387 (THYROIDSHIELDM8-R8TSSMR-SM ). 51. Model Number: R8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-R8TSSMS-MD ), (THYROIDSHIELDM8-R8TSSMS-SM ). 52. Model Number: R8TSSMT; UDI-DI (Product Code): 00840331261400 (THYROIDSHIELDM8-R8TSSMT-MD ), 00840331261417 (THYROIDSHIELDM8-R8TSSMT-SM ). 53. Model Number: R8TSVBN; UDI-DI (Product Code): 00840331261431 (THYROIDSHIELD8-R8TSVBN-MD ). 54. Model Number: R8TSVBR; UDI-DI (Product Code): 00840331261462 (THYROIDSHIELD8-R8TSVBR-MD ), 00840331261479 (THYROIDSHIELD8-R8TSVBR-SM ). 55. Model Number: R8TSVHR; UDI-DI (Product Code): 00840331261547 (THYROIDSHIELD8-R8TSVHR-LG ), 00840331261554 (THYROIDSHIELD8-R8TSVHR-MD ), 00840331261561 (THYROIDSHIELD8-R8TSVHR-SM ). 56. Model Number: R8TSVHT; UDI-DI (Product Code): 00840331261561 (THYROIDSHIELD8-R8TSVHT-MD ), 00840331261622 (THYROIDSHIELD8-R8TSVHT-SM ). 57. Model Number: R8TSVMN; UDI-DI (Product Code): 00840331261646 (THYROIDSHIELDM8-R8TSVMN-MD ), 00840331261653 (THYROIDSHIELDM8-R8TSVMN-SM ). 58. Model Number: R8TSVMR; UDI-DI (Product Code): 00840331261660 (THYROIDSHIELDM8-R8TSVMR-LG ), 00840331261677 (THYROIDSHIELDM8-R8TSVMR-MD ), 00840331261684 (THYROIDSHIELDM8-R8TSVMR-SM ). 59. Model Number: R8TSVMT; UDI-DI (Product Code): 00840331261738 (THYROIDSHIELDM8-R8TSVMT-MD ), 00840331261745 (THYROIDSHIELDM8-R8TSVMT-SM ). 60. Model Number: S8TSBHR; UDI-DI (Product Code): 00840331296006 (THYROIDSHIELDO8-S8TSBHR-MD ). 61. Model Number: S8TSBHT; UDI-DI (Product Code): 00840331264197 (THYROIDSHIELDO8-S8TSBHT-LG ). 62. Model Number: S8TSBMB; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMB-MD ). 63. Model Number: S8TSBMR; UDI-DI (Product Code): 00840331264265 (THYROIDSHIELDOM8-S8TSBMR-MD ), 00840331264272 (THYROIDSHIELDOM8-S8TSBMR-SM ). 64. Model Number: S8TSCBB; UDI-DI (Product Code): 00840331270693 (THYROIDSHIELD8-S8TSCBB-SM ). 65. Model Number: S8TSCBN; UDI-DI (Product Code): 00840331264326 (THYROIDSHIELD8-S8TSCBN-MD ). 66. Model Number: S8TSCBR; UDI-DI (Product Code): 00840331264340 (THYROIDSHIELD8-S8TSCBR-LG ), 00840331264357 (THYROIDSHIELD8-S8TSCBR-MD ), 00840331264364 (THYROIDSHIELD8-S8TSCBR-SM ). 67. Model Number: S8TSCBT; UDI-DI (Product Code): 00840331264388 (THYROIDSHIELD8-S8TSCBT-MD ), 00840331264395 (THYROIDSHIELD8-S8TSCBT-SM ). 68. Model Number: S8TSCHN; UDI-DI (Product Code): 00840331264401 (THYROIDSHIELD8-S8TSCHN-LG ), 00840331264418 (THYROIDSHIELD8-S8TSCHN-MD ). 69. Model Number: S8TSCHR; UDI-DI (Product Code): 00840331264432 (THYROIDSHIELD8-S8TSCHR-LG ), 00840331264449 (THYROIDSHIELD8-S8TSCHR-MD ), 00840331264456 (THYROIDSHIELD8-S8TSCHR-SM ). 70. Model Number: S8TSCHT; UDI-DI (Product Code): 00840331264470 (THYROIDSHIELD8-S8TSCHT-MD ). 71. Model Number: S8TSCMB; UDI-DI (Product Code): 00840331270617 (THYROIDSHIELDM8-S8TSCMB-LG ). 72. Model Number: S8TSCMN; UDI-DI (Product Code): 00840331264517 (THYROIDSHIELDM8-S8TSCMN-SM ). 73. Model Number: S8TSCMR; UDI-DI (Product Code): 00840331264524 (THYROIDSHIELDM8-S8TSCMR-LG ), 00840331264531 (THYROIDSHIELDM8-S8TSCMR-MD ), 00840331264548 (THYROIDSHIELDM8-S8TSCMR-SM ). 74. Model Number: S8TSCMS; UDI-DI (Product Code): 00840331264555 (THYROIDSHIELDM8-S8TSCMS-MD ), 00840331264562 (THYROIDSHIELDM8-S8TSCMS-SM ). 75. Model Number: S8TSCMT; UDI-DI (Product Code): 00840331264579 (THYROIDSHIELDM8-S8TSCMT-LG ), 00840331264586 (THYROIDSHIELDM8-S8TSCMT-MD ), 00840331264593 (THYROIDSHIELDM8-S8TSCMT-SM ). 76. Model Number: S8TSOBR; UDI-DI (Product Code): 00840331264807 (THYROIDSHIELDO8-S8TSOBR-LG ), 00840331264784 (THYROIDSHIELDO8-S8TSOBR-SM ). 77. Model Number: S8TSSBN; UDI-DI (Product Code): 00840331264883 (THYROIDSHIELD8-S8TSSBN-MD ). 78. Model Number: S8TSSBR; UDI-DI (Product Code): 00840331264906 (THYROIDSHIELD8-S8TSSBR-LG ), 00840331264913 (THYROIDSHIELD8-S8TSSBR-MD ), 00840331264920 (THYROIDSHIELD8-S8TSSBR-SM ). 79. Model Number: S8TSSBT; UDI-DI (Product Code): 00840331264944 (THYROIDSHIELD8-S8TSSBT-MD ). 80. Model Number: S8TSSHR; UDI-DI (Product Code): 00840331264999 (THYROIDSHIELD8-S8TSSHR-LG ), 00840331265002 (THYROIDSHIELD8-S8TSSHR-MD ), 00840331265019 (THYROIDSHIELD8-S8TSSHR-SM ). 81. Model Number: S8TSSHS; UDI-DI (Product Code): 00840331271164 (THYROIDSHIELD8-S8TSSHS-MD ). 82. Model Number: S8TSSHT; UDI-DI (Product Code): 00840331265033 (THYROIDSHIELD8-S8TSSHT-MD ). 83. Model Number: S8TSSMN; UDI-DI (Product Code): 00840331265064 (THYROIDSHIELDM8-S8TSSMN-MD ). 84. Model Number: S8TSSMR; UDI-DI (Product Code): 00840331265088 (THYROIDSHIELDM8-S8TSSMR-LG ), 00840331265095 (THYROIDSHIELDM8-S8TSSMR-MD ), 00840331265101 (THYROIDSHIELDM8-S8TSSMR-SM ). 85. Model Number: S8TSSMS; UDI-DI (Product Code): (THYROIDSHIELDM8-S8TSSMS-MD ). 86. Model Number: S8TSSMT; UDI-DI (Product Code): 00840331265118 (THYROIDSHIELDM8-S8TSSMT-LG ), 00840331265132 (THYROIDSHIELDM8-S8TSSMT-SM ). 87. Model Number: S8TSVBB; UDI-DI (Product Code): 00840331271799 (THYROIDSHIELD8-S8TSVBB-MD ). 88. Model Number: S8TSVBR; UDI-DI (Product Code): 00840331265187 (THYROIDSHIELD8-S8TSVBR-MD ). 89. Model Number: S8TSVHR; UDI-DI (Product Code): 00840331265279 (THYROIDSHIELD8-S8TSVHR-MD ), 00840331265286 (THYROIDSHIELD8-S8TSVHR-SM ). 90. Model Number: S8TSVMR; UDI-DI (Product Code): 00840331265392 (THYROIDSHIELDM8-S8TSVMR-MD ), 00840331265408 (THYROIDSHIELDM8-S8TSVMR-SM ). 91. Model Number: U8TSBBR; UDI-DI (Product Code): 00840331267853 (THYROIDSHIELDO8-U8TSBBR-SM ). 92. Model Number: U8TSBMN; UDI-DI (Product Code): 00840331267990 (THYROIDSHIELDOM8-U8TSBMN-MD ). 93. Model Number: U8TSBMR; UDI-DI (Product Code): 00840331268010 (THYROIDSHIELDOM8-U8TSBMR-LG ), 00840331268027 (THYROIDSHIELDOM8-U8TSBMR-MD ). 94. Model Number: U8TSCBN; UDI-DI (Product Code): 00840331268089 (THYROIDSHIELD8-U8TSCBN-MD ). 95. Model Number: U8TSCBR; UDI-DI (Product Code): 00840331268102 (THYROIDSHIELD8-U8TSCBR-LG ), 00840331268119 (THYROIDSHIELD8-U8TSCBR-MD ), 00840331268126 (THYROIDSHIELD8-U8TSCBR-SM ). 96. Model Number: U8TSCBT; UDI-DI (Product Code): 00840331268140 (THYROIDSHIELD8-U8TSCBT-MD ). 97. Model Number: U8TSCHR; UDI-DI (Product Code): 00840331268201 (THYROIDSHIELD8-U8TSCHR-MD ), 00840331268218 (THYROIDSHIELD8-U8TSCHR-SM ). 98. Model Number: U8TSCMR; UDI-DI (Product Code): 00840331268294 (THYROIDSHIELDM8-U8TSCMR-MD ), 00840331268300 (THYROIDSHIELDM8-U8TSCMR-SM ). 99. Model Number: U8TSCMT; UDI-DI (Product Code): 00840331268324 (THYROIDSHIELDM8-U8TSCMT-MD ), 00840331268331 (THYROIDSHIELDM8-U8TSCMT-SM ). 100. Model Number: U8TSOMR; UDI-DI (Product Code): 00840331268560 (THYROIDSHIELDOM8-U8TSOMR-MD ). 101. Model Number: U8TSSBN; UDI-DI (Product Code): 00840331268621 (THYROIDSHIELD8-U8TSSBN-MD ). 102. Model Number: U8TSSBR; UDI-DI (Product Code): 00840331268652 (THYROIDSHIELD8-U8TSSBR-MD ). 103. Model Number: U8TSSHN; UDI-DI (Product Code): 00840331268713 (THYROIDSHIELD8-U8TSSHN-MD ). 104. Model Number: U8TSSHR; UDI-DI (Product Code): 00840331268737 (THYROIDSHIELD8-U8TSSHR-LG ), 00840331268744 (THYROIDSHIELD8-U8TSSHR-MD ). 105. Model Number: U8TSSMR; UDI-DI (Product Code): 00840331268829 (THYROIDSHIELDM8-U8TSSMR-LG ), 00840331268836 (THYROIDSHIELDM8-U8TSSMR-MD ), 00840331268843 (THYROIDSHIELDM8-U8TSSMR-SM ). 106. Model Number: U8TSSMS; UDI-DI (Product Code): None (THYROIDSHIELDM8-U8TSSMS-SM ). 107. Model Number: U8TSSMT; UDI-DI (Product Code): 00840331268867 (THYROIDSHIELDM8-U8TSSMT-MD ), 00840331268874 (THYROIDSHIELDM8-U8TSSMT-SM ). 108. Model Number: U8TSVMR; UDI-DI (Product Code): 00840331269130 (THYROIDSHIELDM8-U8TSVMR-MD ), 00840331269147 (THYROIDSHIELDM8-U8TSVMR-SM ).
Burlington Medical, Caps.
UDI-DI
00840331272185
00840331272178
00840331272208
00840331272192
00840331272222
00840331272215
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8CAP; UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP; UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP; UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD).
Burlington Medical, Kilt
UDI-DI
00840331297638
00197513003618
00197513002932
00197513002925
00197513002918
00197513002901
00197513002888
00197513002871
00197513002864
00197513000068
00197513000198
00840331259681
00840331259698
00840331259704
00840331259711
00840331259728
00840331259735
00840331259759
00840331259766
00840331259773
00840331259780
00840331259797
00840331259803
00840331259810
00840331259827
00840331259742
00840331269925
00840331269932
00197513004950
00197513004943
00197513004936
00197513004929
00197513004912
00197513004905
00197513004899
00197513004875
00197513000327
00197513000457
00840331260182
00840331260205
00840331260250
00840331269987
00840331269994
00840331270013
00197513002802
00197513002796
00197513002789
00197513002734
00197513002727
00197513000051
00197513000181
00840331263435
00840331263442
00840331263459
00840331263466
00840331263473
00840331263480
00840331263497
00840331263503
00840331263510
00840331263527
00840331263534
00840331263541
00840331263558
00840331263565
00840331269949
00840331269956
00197513004837
00197513004820
00197513004813
00197513004806
00197513004790
00197513000310
00197513000440
00840331270006
00197513002680
00197513002673
00197513002666
00197513002642
00197513002635
00197513000174
00197513000044
00840331267167
00840331267174
00840331267181
00840331267204
00840331267211
00840331267228
00840331267235
00840331267242
00840331267259
00840331267266
00840331267273
00840331267280
00840331267297
00840331267303
00840331269963
00840331269970
00197513004714
00197513004691
00197513004684
00197513004677
00197513004660
00197513004622
00197513000303
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: C8K303; UDI-DI (Product Code): 00840331297638 (FKILTC18-C8K303-2XM, FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF, FKILTC8-C8K303-SM, FKILTC8-C8K303-XLF, FKILTC8-C8K303-XLM, FKILTC8-C8K303-XSF, FKILTT18-C8K303-LM, FKILTT18-C8K303-MM, FKILTT18-C8K303-PLUS, FKILTT18-C8K303-SM, FKILTT18-C8K303-XLM, FKILTT18-C8K303-XSM, FKILTT28-C8K303-2XM, FKILTT28-C8K303-4XM, FKILTT28-C8K303-5XM). 2. Model Number: R8K303; UDI-DI (Product Code): 00197513003618 (FKILTC18-R8K303-2XF ), 00197513003618 (FKILTC18-R8K303-3XF ), 00197513002932 (FKILTC8-R8K303-LF ), 00197513002925 (FKILTC8-R8K303-LM ), 00197513002918 (FKILTC8-R8K303-MF ), 00197513002901 (FKILTC8-R8K303-MM ), 00197513002888 (FKILTC8-R8K303-SF ), 00197513002871 (FKILTC8-R8K303-SM ), 00197513002864 (FKILTC8-R8K303-XLF ), 00197513000068 (FKILTT18-R8K303-LF ), 00197513000198 (FKILTT18-R8K303-LM ), 00197513000068 (FKILTT18-R8K303-MF ), 00197513000198 (FKILTT18-R8K303-MM ), 00197513000068 (FKILTT18-R8K303-PLUS ), 00197513000068 (FKILTT18-R8K303-SF ), 00197513000198 (FKILTT18-R8K303-SM ), 00197513000068 (FKILTT18-R8K303-XLF ), 00197513000198 (FKILTT18-R8K303-XLM ), 00197513000198 (FKILTT18-R8K303-XSM ), 00197513000068 (FKILTT28-R8K303-2XF ), 00197513000068 (FKILTT28-R8K303-3XF ), 00197513000198 (FKILTT28-R8K303-3XM ), 00197513000068 (FKILTT28-R8K303-4XF ), 00197513000068 (FKILTT38-R8K303-6XF ). 3. Model Number: R8KILT; UDI-DI (Product Code): None (IKILTC8-R8KILT-LMR ), None (IKILTC8-R8KILT-SMR ), 00840331259681 (KILTC18-R8KILT-2XF ), 00840331259698 (KILTC18-R8KILT-2XM ), 00840331259704 (KILTC18-R8KILT-3XF ), 00840331259711 (KILTC18-R8KILT-3XM ), 00840331259728 (KILTC8-R8KILT-LF ), 00840331259735 (KILTC8-R8KILT-LM ), 00840331259735 (KILTC8-R8KILT-MF ), 00840331259759 (KILTC8-R8KILT-MM ), 00840331259766 (KILTC8-R8KILT-PLUS ), 00840331259773 (KILTC8-R8KILT-SF ), 00840331259780 (KILTC8-R8KILT-SM ), 00840331259797 (KILTC8-R8KILT-XLF ), 00840331259803 (KILTC8-R8KILT-XLM ), 00840331259810 (KILTC8-R8KILT-XSF ), 00840331259827 (KILTC8-R8KILT-XSM ), 00840331259728 (KILTS8-R8KILT-LF ), 00840331259735 (KILTS8-R8KILT-LM ), 00840331259742 (KILTS8-R8KILT-MF ), 00840331259759 (KILTS8-R8KILT-MM ), 00840331259766 (KILTS8-R8KILT-PLUS ), 00840331259773 (KILTS8-R8KILT-SF ), 00840331259780 (KILTS8-R8KILT-SM ), 00840331259797 (KILTS8-R8KILT-XLF ), 00840331259803 (KILTS8-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-LF ), 00840331269932 (KILTT18-R8KILT-LM ), 00840331269925 (KILTT18-R8KILT-MF ), 00840331269932 (KILTT18-R8KILT-MM ), 00840331269925 (KILTT18-R8KILT-PLUS ), 00840331269925 (KILTT18-R8KILT-SF ), 00840331269932 (KILTT18-R8KILT-SM ), 00840331269925 (KILTT18-R8KILT-XLF ), 00840331269932 (KILTT18-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-XSF ), 00840331269932 (KILTT18-R8KILT-XSM ), 00840331269925 (KILTT28-R8KILT-2XF ), 00840331269932 (KILTT28-R8KILT-2XM ), 00840331269925 (KILTT28-R8KILT-3XF ), 00840331269932 (KILTT28-R8KILT-3XM ), 00840331269925 (KILTT28-R8KILT-4XF ), 00840331269932 (KILTT28-R8KILT-4XM ), 00840331269925 (KILTT28-R8KILT-5XF ), 00840331269932 (KILTT28-R8KILT-5XM ), 00840331269925 (KILTT38-R8KILT-6XF ), 00840331269932 (KILTT38-R8KILT-6XM ), 00840331269925 (KILTT38-R8KILT-7XF ), 00840331269932 (KILTT38-R8KILT-7XM ), 00840331269925 (KILTT38-R8KILT-8XF ), 00840331269932 (KILTT38-R8KILT-8XM ), None (IKILTC8-R8KILT-LFL ), None (IKILTC8-R8KILT-LFR ), None (IKILTC8-R8KILT-MFL ), None (IKILTC8-R8KILT-MFR ), None (IKILTC8-R8KILT-MFXL ), None (IKILTC8-R8KILT-MML ), None (IKILTC8-R8KILT-MMR ), None (IKILTC8-R8KILT-SFL ), None (IKILTC8-R8KILT-SML ), None (IKILTC8-R8KILT-XSFR ), None (IKILTC8-R8KILT-2XFL ), None (IKILTC8-R8KILT-2XFR ), None (IKILTC8-R8KILT-3XFR ), None (IKILTC8-R8KILT-LFS ), None (IKILTC8-R8KILT-LML ), None (IKILTC8-R8KILT-LMXL ), None (IKILTC8-R8KILT-MFS ), None (IKILTC8-R8KILT-SFS ), None (IKILTC8-R8KILT-XLMR ), None (IKILTC8-R8KILT-2XMXL ), None (IKILTC8-R8KILT-PLUSL ), None (IKILTC8-R8KILT-SFR ), None (IKILTC8-R8KILT-XLML ), None (IKILTC8-R8KILT-XSFS ), None (IKILTC8-R8KILT-MMXL ), None (IKILTC8-R8KILT-XLMXL ), None (IKILTC8-R8KILT-2XMR ), None (IKILTC8-R8KILT-XSML ), None (IKILTC8-R8KILT-XSMR ), None (IKILTC8-R8KILT-XSMXL ), None (IFKILTC8-R8K303-LFR), None (IFKILTC8-R8K303-MMR). 4. Model Number: R8S302; UDI-DI (Product Code): 00197513004950 (SKIRTWBC8-R8S302-LF ), 00197513004943 (SKIRTWBC8-R8S302-LM ), 00197513004936 (SKIRTWBC8-R8S302-MF ), 00197513004929 (SKIRTWBC8-R8S302-MM ), 00197513004912 (SKIRTWBC8-R8S302-PLUS ), 00197513004905 (SKIRTWBC8-R8S302-SF ), 00197513004899 (SKIRTWBC8-R8S302-SM ), 00197513004875 (SKIRTWBC8-R8S302-XLM ), 00197513000327 (SKIRTWBT18-R8S302-LF ), 00197513000457 (SKIRTWBT18-R8S302-LM ), 00197513000327 (SKIRTWBT18-R8S302-MF ), 00197513000457 (SKIRTWBT18-R8S302-MM ), 00197513000327 (SKIRTWBT18-R8S302-PLUS ), 00197513000457 (SKIRTWBT18-R8S302-SM ), 00197513000327 (SKIRTWBT18-R8S302-XLF ), 00197513000457 (SKIRTWBT18-R8S302-XLM ), 00197513000457 (SKIRTWBT28-R8S302-2XM ), 00197513000327 (SKIRTWBT28-R8S302-3XF ), 00197513000457 (SKIRTWBT28-R8S302-3XM ), 00197513000457 (SKIRTWBT28-R8S302-4XM ), 00197513000327 (SKIRTWBT28-R8S302-5XF ), 00197513000457 (SKIRTWBT28-R8S302-5XM ), 00197513000327 (SKIRTWBT38-R8S302-6XF ), 00197513000457 (SKIRTWBT38-R8S302-6XM ), 00197513000327 (SKIRTWBT38-R8S302-8XF ), 00197513000457 (SKIRTWBT38-R8S302-8XM ), None (ISKIRTWBC8-R8S302-MFL ), None (ISKIRTWBC8-R8S302-MFR ), None (ISKIRTWBC8-R8S302-MML ), None (ISKIRTWBC8-R8S302-MMR ), None (ISKIRTWBC8-R8S302-MMXL ), None (ISKIRTWBC8-R8S302-PLUSL ), None (ISKIRTWBC8-R8S302-SFL ), None (ISKIRTWBC8-R8S302-SML ). 5. Model Number: R8SKIRT; UDI-DI (Product Code): 00840331260182 (SKIRTC8-R8SKIRT-LM ), 00840331260205 (SKIRTC8-R8SKIRT-MM ), 00840331260250 (SKIRTC8-R8SKIRT-XLM ), 00840331269987 (SKIRTT18-R8SKIRT-LF ), 00840331269994 (SKIRTT18-R8SKIRT-LM ), 00840331269987 (SKIRTT18-R8SKIRT-MF ), 00840331269994 (SKIRTT18-R8SKIRT-MM ), 00840331269987 (SKIRTT18-R8SKIRT-PLUS ), 00840331269994 (SKIRTT18-R8SKIRT-SM ), 00840331269987 (SKIRTT18-R8SKIRT-XLF ), 00840331269994 (SKIRTT18-R8SKIRT-XLM ), 00840331269994 (SKIRTT18-R8SKIRT-XSM ), 00840331269987 (SKIRTT28-R8SKIRT-2XF ), 00840331269994 (SKIRTT28-R8SKIRT-2XM ), 00840331269994 (SKIRTT28-R8SKIRT-3XM ), 00840331269994 (SKIRTT28-R8SKIRT-4XM ), 00840331270013 (SKIRTT38-R8SKIRT-6XM ). 6. Model Number: S8K303; UDI-DI (Product Code): 00197513002802 (FKILTC8-S8K303-LM ), 00197513002796 (FKILTC8-S8K303-MF ), 00197513002789 (FKILTC8-S8K303-MM ), 00197513002734 (FKILTC8-S8K303-XLM ), 00197513002727 (FKILTC8-S8K303-XSF ), 00197513000051 (FKILTT18-S8K303-MF ), 00197513000181 (FKILTT18-S8K303-MM ), 00197513000051 (FKILTT18-S8K303-PLUS ), 00197513000181 (FKILTT18-S8K303-SM ), 00197513000181 (FKILTT18-S8K303-XSM ), 00197513000181 (FKILTT28-S8K303-2XM ), 00197513000051 (FKILTT28-S8K303-3XF ), 00197513000181 (FKILTT28-S8K303-3XM ), 00197513000181 (FKILTT28-S8K303-4XM ). 7. Model Number: S8KILT; UDI-DI (Product Code): 00840331263435 (KILTC18-S8KILT-2XF ), 00840331263442 (KILTC18-S8KILT-2XM ), 00840331263459 (KILTC18-S8KILT-3XF ), 00840331263466 (KILTC18-S8KILT-3XM ), 00840331263473 (KILTC8-S8KILT-LF ), 00840331263480 (KILTC8-S8KILT-LM ), 00840331263497 (KILTC8-S8KILT-MF ), 00840331263503 (KILTC8-S8KILT-MM ), 00840331263510 (KILTC8-S8KILT-PLUS ), 00840331263527 (KILTC8-S8KILT-SF ), 00840331263534 (KILTC8-S8KILT-SM ), 00840331263541 (KILTC8-S8KILT-XLF ), 00840331263558 (KILTC8-S8KILT-XLM ), 00840331263565 (KILTC8-S8KILT-XSF ), 00840331263565 (KILTC8-S8KILT-XSM ), 00840331263473 (KILTS8-S8KILT-LF ), 00840331263480 (KILTS8-S8KILT-LM ), 00840331263497 (KILTS8-S8KILT-MF ), 00840331263503 (KILTS8-S8KILT-MM ), 00840331263527 (KILTS8-S8KILT-SF ), 00840331263534 (KILTS8-S8KILT-SM ), 00840331263541 (KILTS8-S8KILT-XLF ), 00840331263558 (KILTS8-S8KILT-XLM ), 00840331269949 (KILTT18-S8KILT-LF ), 00840331269956 (KILTT18-S8KILT-LM ), 00840331269949 (KILTT18-S8KILT-MF ), 00840331269956 (KILTT18-S8KILT-MM ), 00840331269949 (KILTT18-S8KILT-PLUS ), 00840331269949 (KILTT18-S8KILT-SF ), 00840331269956 (KILTT18-S8KILT-SM ), 00840331269949 (KILTT18-S8KILT-XLF ), 00840331269956 (KILTT18-S8KILT-XLM ), 00840331269949 (KILTT18-S8KILT-XSF ), 00840331269956 (KILTT18-S8KILT-XSM ), 00840331269949 (KILTT28-S8KILT-2XF ), 00840331269956 (KILTT28-S8KILT-2XM ), 00840331269949 (KILTT28-S8KILT-3XF ), 00840331269956 (KILTT28-S8KILT-3XM ), 00840331269949 (KILTT28-S8KILT-4XF ), 00840331269956 (KILTT28-S8KILT-4XM ), 00840331269949 (KILTT28-S8KILT-5XF ), 00840331269956 (KILTT28-S8KILT-5XM ), 00840331269949 (KILTT38-S8KILT-6XF ), 00840331269956 (KILTT38-S8KILT-6XM ), 00840331269949 (KILTT38-S8KILT-7XF ), 00840331269956 (KILTT38-S8KILT-7XM ), 00840331269949 (KILTT38-S8KILT-8XF ), 00840331269956 (KILTT38-S8KILT-8XM ), None (IKILTC8-S8KILT-LMR ), None (IKILTC8-S8KILT-MMR ). 8. Model Number: S8S302; UDI-DI (Product Code): 00197513004837 (SKIRTWBC8-S8S302-LF ), 00197513004820 (SKIRTWBC8-S8S302-LM ), 00197513004813 (SKIRTWBC8-S8S302-MF), 00197513004806 (SKIRTWBC8-S8S302-MM ), 00197513004790 (SKIRTWBC8-S8S302-PLUS), 00197513000310 (SKIRTWBT18-S8S302-LF ), 00197513000440 (SKIRTWBT18-S8S302-LM), 00197513000310 (SKIRTWBT18-S8S302-MF ), 00197513000440 (SKIRTWBT18-S8S302-MM), 00197513000310 (SKIRTWBT18-S8S302-PLUS ), 00197513000440 (SKIRTWBT18-S8S302-SM ), 00197513000310 (SKIRTWBT18-S8S302-XLF ), 00197513000440 (SKIRTWBT18-S8S302-XLM ), 00197513000440 (SKIRTWBT18-S8S302-XSM ), 00197513000310 (SKIRTWBT28-S8S302-3XF ), 00197513000440 (SKIRTWBT28-S8S302-3XM), 00197513000440 (SKIRTWBT28-S8S302-4XM ), 00197513000440 (SKIRTWBT28-S8S302-5XM ). 9. Model Number: S8SKIRT; UDI-DI (Product Code): 00840331270006 (SKIRTT18-S8SKIRT-LF ), 00840331270013 (SKIRTT18-S8SKIRT-LM ), 00840331270006 (SKIRTT18-S8SKIRT-MF ), 00840331270006 (SKIRTT18-S8SKIRT-PLUS ), 00840331270013 (SKIRTT18-S8SKIRT-SM ), 00840331270006 (SKIRTT18-S8SKIRT-XLF ), 00840331270006 (SKIRTT28-S8SKIRT-3XF ), 00840331270013 (SKIRTT28-S8SKIRT-4XM ). 10. Model Number: U8K303; UDI-DI (Product Code): 00197513002680 (FKILTC8-U8K303-LM), 00197513002673 (FKILTC8-U8K303-MF ), 00197513002666 (FKILTC8-U8K303-MM ), 00197513002642 (FKILTC8-U8K303-SF ), 00197513002635 (FKILTC8-U8K303-SM ), 00197513000174 (FKILTT18-U8K303-LM ), 00197513000044 (FKILTT18-U8K303-MF ), 00197513000174 (FKILTT18-U8K303-MM ), 00197513000044 (FKILTT18-U8K303-PLUS ), 00197513000174 (FKILTT18-U8K303-SM ), 00197513000174 (FKILTT28-U8K303-2XM ), 00197513000044 (FKILTT28-U8K303-4XF ), 00197513000174 (FKILTT28-U8K303-4XM ), 00197513000044 (FKILTT28-U8K303-5XF ), 00197513000174 (FKILTT28-U8K303-5XM ), None (IFKILTC8-U8K303-2XMR ), None (IFKILTC8-U8K303-LMR ), None (IFKILTC8-U8K303-MMR ), None (IFKILTC8-U8K303-SFR ), None (IFKILTC8-U8K303-SMR ), None (IFKILTC8-U8K303-XLMR ). 11. Model Number: U8KILT; UDI-DI (Product Code): 00840331267167 (KILTC18-U8KILT-2XF ), 00840331267174 (KILTC18-U8KILT-2XM ), 00840331267181 (KILTC18-U8KILT-3XF ), 00840331267204 (KILTC8-U8KILT-LF ), 00840331267211 (KILTC8-U8KILT-LM ), 00840331267228 (KILTC8-U8KILT-MF ), 00840331267235 (KILTC8-U8KILT-MM ), 00840331267242 (KILTC8-U8KILT-PLUS ), 00840331267259 (KILTC8-U8KILT-SF ), 00840331267266 (KILTC8-U8KILT-SM ), 00840331267273 (KILTC8-U8KILT-XLF ), 00840331267280 (KILTC8-U8KILT-XLM ), 00840331267297 (KILTC8-U8KILT-XSF ), 00840331267303 (KILTC8-U8KILT-XSM ), 00840331267204 (KILTS8-U8KILT-LF ), 00840331267211 (KILTS8-U8KILT-LM ), 00840331267228 (KILTS8-U8KILT-MF ), 00840331269963 (KILTT18-U8KILT-LF ), 00840331269970 (KILTT18-U8KILT-LM ), 00840331269963 (KILTT18-U8KILT-MF ), 00840331269970 (KILTT18-U8KILT-MM ), 00840331269963 (KILTT18-U8KILT-PLUS ), 00840331269963 (KILTT18-U8KILT-SF ), 00840331269970 (KILTT18-U8KILT-SM ), 00840331269963 (KILTT18-U8KILT-XLF ), 00840331269970 (KILTT18-U8KILT-XLM ), 00840331269970 (KILTT18-U8KILT-XSM ), 00840331269963 (KILTT28-U8KILT-2XF ), 00840331269970 (KILTT28-U8KILT-2XM ), 00840331269963 (KILTT28-U8KILT-3XF ), 00840331269970 (KILTT28-U8KILT-3XM ), 00840331269963 (KILTT28-U8KILT-4XF ), 00840331269970 (KILTT28-U8KILT-4XM ), 00840331269963 (KILTT28-U8KILT-5XF ), 00840331269970 (KILTT28-U8KILT-5XM ), 00840331269963 (KILTT38-U8KILT-6XF ), 00840331269970 (KILTT38-U8KILT-6XM ), 00840331269963 (KILTT38-U8KILT-7XF ), 00840331269970 (KILTT38-U8KILT-7XM ), 00840331269963 (KILTT38-U8KILT-8XF ), 00840331269970 (KILTT38-U8KILT-8XM ), None (IKILTC8-U8KILT-2XMR ), None (IKILTC8-U8KILT-LFR ), None (IKILTC8-U8KILT-LMR ), None (IKILTC8-U8KILT-LMXL ), None (IKILTC8-U8KILT-MFR ), None (IKILTC8-U8KILT-MMR ), None (IKILTC8-U8KILT-SFR ), None (IKILTC8-U8KILT-SMR ), None (IKILTC8-U8KILT-XLMR ), None (IKILTC8-U8KILT-XLMXL ), None (IKILTC8-U8KILT-XSFR ). 12. Model Number: U8S302; UDI-DI (Product Code): 00197513004714 (SKIRTWBC8-U8S302-LF ), 00197513004691 (SKIRTWBC8-U8S302-MF ), 00197513004684 (SKIRTWBC8-U8S302-MM ), 00197513004677 (SKIRTWBC8-U8S302-PLUS ), 00197513004660 (SKIRTWBC8-U8S302-SF ), 00197513004622 (SKIRTWBC8-U8S302-XSF ), 00197513000303 (SKIRTWBT18-U8S302-PLUS ).
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
UDI-DI
00197513011941
00197513011934
00197513011927
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: BATB; UDI-DI (Product Code): 00197513011941 (BATC18-R8BATB-2XF ), 00197513011941 (BATC18-R8BATB-3XF ), 00197513011941 (BATC8-R8BATB-LF ), 00197513011941 (BATC8-R8BATB-LM ), 00197513011941 (BATC8-R8BATB-MF ), 00197513011941 (BATC8-R8BATB-MM ), 00197513011941 (BATC8-R8BATB-PLUS ), 00197513011941 (BATC8-R8BATB-SF ), 00197513011941 (BATC8-R8BATB-XLF ), 00197513011941 (BATC8-R8BATB-XLM ), 00197513011941 (BATC8-R8BATB-XSF ). 2. Model Number: BATH; UDI-DI (Product Code): 00197513011934 (BATC18-R8BATH-2XF ), 00197513011934 (BATC18-R8BATH-2XM ), 00197513011934 (BATC18-R8BATH-3XF ), 00197513011934 (BATC18-R8BATH-3XM ), 00197513011934 (BATC8-R8BATH-LF ), 00197513011934 (BATC8-R8BATH-LM ), 00197513011934 (BATC8-R8BATH-MF ), 00197513011934 (BATC8-R8BATH-MM ), 00197513011934 (BATC8-R8BATH-PLUS ), 00197513011934 (BATC8-R8BATH-SF ), 00197513011934 (BATC8-R8BATH-SM ), 00197513011934 (BATC8-R8BATH-XLF ), 00197513011934 (BATC8-R8BATH-XLM ), 00197513011934 (BATC8-R8BATH-XSF ), 00197513011934 (BATC8-R8BATH-XLF ). 3. Model Number: BATM; UDI-DI (Product Code): 00197513011927 (BATC18-R8BATM-2XF ), 00197513011927 (BATC18-R8BATM-2XM ), 00197513011927 (BATC18-R8BATM-3XF ), 00197513011927 (BATC18-R8BATM-3XM ), 00197513011927 (BATC8-R8BATM-LF ), 00197513011927 (BATC8-R8BATM-LM ), 00197513011927 (BATC8-R8BATM-MF ), 00197513011927 (BATC8-R8BATM-MM ), 00197513011927 (BATC8-R8BATM-PLUS ), 00197513011927 (BATC8-R8BATM-SF ), 00197513011927 (BATC8-R8BATM-SM ), 00197513011927 (BATC8-R8BATM-XLF ), 00197513011927 (BATC8-R8BATM-XLM ), 00197513011927 (BATC8-R8BATM-XSF ), 00197513011927 (BATC8-R8BATM-XSM ).
Burlington Medical, Demi Half Aprons.
UDI-DI
00197513001485
00197513001478
00197513001461
00197513001492
00197513001607
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8DHALFR; UDI-DI (Product Code): 00197513001485 (DHALF8-R8DHALFR-L), 00197513001478 (DHALF8-R8DHALFR-M), 00197513001461 (DHALF8-R8DHALFR-S), 00197513001492 (DHALF8-R8DHALFR-XL), 00197513001607 (DHALFSET8-R8DHALFR-SET).
Burlington Medical, Kilt Blockers.
UDI-DI
00840331272727
00197513011293
00840331272741
00840331272758
00840331272765
00840331272772
00840331272789
00197513011309
00840331272802
00840331272819
00840331272826
00197513011316
00840331272864
00840331272871
00840331272888
Lot code
All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272727 (KILTBLOCKER8-R8KILTBLOCKER10X12). 2. Model Number: R8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011293 (KILTBLOCKER8-R8KILTBLOCKER12X12). 3. Model Number: R8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272741 (KILTBLOCKER8-R8KILTBLOCKER18X20). 4. Model Number: R8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272758 (KILTBLOCKER8-R8KILTBLOCKER20X24). 5. Model Number: R8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272765 (KILTBLOCKER8-R8KILTBLOCKER24X24). 6. Model Number: S8KILTBLOCKER10X10; UDI-DI (Product Code): 00840331272772 (KILTBLOCKER8-S8KILTBLOCKER10X10). 7. Model Number: S8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272789 (KILTBLOCKER8-S8KILTBLOCKER10X12). 8. Model Number: S8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011309 (KILTBLOCKER8-S8KILTBLOCKER12X12). 9. Model Number: S8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272802 (KILTBLOCKER8-S8KILTBLOCKER18X20). 10. Model Number: S8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272819 (KILTBLOCKER8-S8KILTBLOCKER20X24). 11. Model Number: S8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272826 (KILTBLOCKER8-S8KILTBLOCKER24X24). 12. Model Number: U8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011316 (KILTBLOCKER8-U8KILTBLOCKER12X12). 13. Model Number: U8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272864 (KILTBLOCKER8-U8KILTBLOCKER18X20). 14. Model Number: U8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272871 (KILTBLOCKER8-U8KILTBLOCKER20X24). 15. Model Number: U8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272888 (KILTBLOCKER8-U8KILTBLOCKER24X24).

Recall details

Company began the recall

Feb 11, 2026

Sold in

Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.

Company

Burlington Medical, LLCNewport News, Virginia

Hazard

Device defect

Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID

98415

Recall numbers

Z-1753-2026 to Z-1765-2026

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

Feb 11, 2026
Company began the recall
Apr 2, 2026
Added to FDA's Enforcement Report · Classified by FDA
Apr 8, 2026
In FDA's weekly enforcement report
Apr 23, 2026
Listed on Recall Canary
Oct 3, 2026
Summary updated

What happened

What to do

Is yours affected?

Burlington Medical, Wrap Aprons.

Burlington Medical, Leg Wraps.

Burlington Medical, Half Aprons.

Burlington Medical, Vest

Burlington Medical, Frontal Aprons

Burlington Medical, Protective Sleeves.

Burlington Medical, Blockers.

Burlington Medical, Thyroid Shield.

Burlington Medical, Caps.

Burlington Medical, Kilt

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

Burlington Medical, Demi Half Aprons.

Burlington Medical, Kilt Blockers.

Recall details

Timeline

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