FDA recall, , Moderate risk
ICU Medical Tego Connector
The Tego Connector has a silicone seal that may bulge, separate, or tear, causing fluid leaks and therapy interruption.
Summary by Recall Canary from the FDA notice
What happened
ICU Medical, Inc., of San Clemente, California, recalled the Tego Connector, a needle free access device intended as an accessory to vascular access used in hemodialysis or accessory to intravascular administration sets, because the silicone seal may bulge at the top, separate from the body, or tear, which may result in fluid leaks, occluded fluid flow, inability to inject or withdraw blood product, delayed or interrupted therapy, exposure to biological contaminants, and air infused into the body.
The company began the recall on December 19, 2025, and the FDA added it to the Enforcement Report on January 16, 2026.
The recalled products include Tego Connector REFs 011-D1000, 01C-D1000, 055-D1000, D1000, and Conector Tego REF LAT-D1000.
The recall covers 14,684,607 items distributed worldwide, including US Nationwide distribution and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.
The FDA classified the recall on January 16, 2026, and it was listed in the weekly enforcement report on January 28, 2026.
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?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
- UDI-DI
- 00840619026059
- 00840619006785
- 14015455
- 14044313
- 14228823
- 14274294
- 14171414
- 14304670
- 13772668
- 13778926
- 13791786
- 13794986
- 13797963
- 13801102
- 13806764
- 13812991
- 13822705
- 13828556
- 13833879
- 13838937
- 13867515
- 13875052
- 13876502
- 13876503
- 13882254
- 13882256
- 13887995
- 13887996
- 13894349
- 13894350
- 13903971
- 13903972
- 14045054
- 14045055
- 14049379
- 14049404
- 14063784
- 14063785
- 14071890
- 14071891
- 14071892
- 14087320
- 14090798
- 14110500
- 14131560
- 14144999
- 14145000
- 14150873
- 14150874
- 14150875
- 14170224
- 14170226
- 14179702
- 14179704
- 14179706
- 14208522
- 14208523
- 14212866
- 14212870
- 14216154
- 14216155
- 14224623
- 14248560
- 14248561
- 14274291
- 1427429291
- 14278257
- 14278258
- 14278259
- 14278260
- 14300970
- 14300972
- 14303936
- 13768000
- 13772666
- 13778922
- 13778923
- 13778925
- 13791783
- 13791784
- 13791785
- 13792328
- 13794980
- 13794982
- 13794984
- 13801099
- 13801100
- 13801101
- 13806761
- 13806762
- 13806763
- 13812988
- 13812989
- 13812990
- 13822693
- 13822697
- 13822701
- 13825588
- 13828548
- 13828551
- 13828553
- 13833876
- 13833877
- 13833878
- 13838931
- 13838933
- 13838935
- 13848442
- 13848444
- 13848445
- 13854647
- 13854648
- 13854649
- 13858987
- 13859857
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- 13859859
- 13867512
- 13867514
- 13876507
- 13876508
- 13876509
- 13882259
- 13882260
- 13887205
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- 13887997
- 13894351
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- 13894353
- 13903974
- 13903975
- 13903976
- 13903977
- 13910270
- 13910272
- 13938363
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- 13938366
- 13943704
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- 13943712
- 13943720
- 13949234
- 13953949
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- 13955847
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- 13959944
- 13959950
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- 13971720
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- 13999996
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- 13999999
- 14000000
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- 14000003
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- 14041792
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- 14041798
- 14041800
- 14056392
- 14056393
- 14056395
- 14056397
- 14056398
- 14056399
- 14056400
- 14063790
- 14063791
- 14063792
- 14071894
- 14071895
- 14087321
- 14087322
- 14087323
- 14090800
- 14090801
- 14097661
- 14097662
- 14100193
- 14100198
- 14110501
- 14110502
- 14110503
- 14110505
- 14115072
- 14115073
- 14115074
- 14115075
- 14115076
- 14131561
- 14131562
- 14131563
- 14131564
- 14135720
- 14135721
- 14135722
- 14135723
- 14135725
- 14145003
- 14145004
- 14145005
- 14147959
- 14150877
- 14150878
- 14150880
- 14162155
- 14170227
- 14170231
- 14170232
- 14179721
- 14183938
- 14183940
- 14183941
- 14192702
- 14192703
- 14201160
- 14201161
- 14201162
- 14201163
- 14201165
- 14216156
- 14216157
- 14219693
- 14219694
- 14224627
- 14224630
- 14226006
- 14226007
- 14226008
- 14226009
- 14226010
- 14226011
- 14226012
- 14226013
- 14228825
- 14228826
- 14228828
- 14228832
- 14244970
- 14244971
- 14244977
- 14244978
- 14244980
- 14251976
- 14251977
- 14251979
- 14251980
- 14251983
- 14251984
- 14251985
- 14251986
- 14265939
- 14265940
- 14265941
- 14265942
- 14265943
- 14289207
- 14292935
- 14292936
- 14300977
- 14300979
- 14307683
- 14307684
- 14307685
- 13768003
- 13778927
- 13812992
- 13848447
- 13867516
- 14015450
- 14044312
- 14063789
- 14090799
- 14145002
- 14228820
- 14228821
- 14228822
- 14274293
- 14274302
- 14307682
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Florida, Arizona, Rhode Island, Tennessee, Kansas, New Jersey, New York, Virginia, South Carolina, Georgia, California, Mississippi, Texas, Ohio, North Carolina, Massachusetts, Washington, Illinois, Pennsylvania, Nevada, New Hampshire, Louisiana, Michigan, Nebraska, Maine, Minnesota, New Mexico, Oklahoma, Maryland, Iowa, Oregon, South Dakota, Wisconsin, Missouri, Alabama, Wyoming, Indiana, Kentucky, District of Columbia, Utah, Arkansas, West Virginia, Alaska, North Dakota, Colorado and the countries of BE, Delaware, Colorado, ES, AU, Arkansas, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, California, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, Massachusetts, HK.
- Company
- ICU Medical, Inc.San Clemente, California
- Hazard
- Contamination
- 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
- 98150
- Recall number
- Z-1111-2026
- Quantity recalled
- 14,684,607 items
All recalls from ICU Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
