FDA recall, , Moderate risk
Medline Bronchoscopy and Airway Kits
Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP of Northfield, Illinois is recalling Thoracic Robots, Airway Exam Kit, and Medline kits containing Olympus biopsy valves, because the kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves.
Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal.
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 your kit affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline kits containing Olympus biopsy valves
- UDI-DI
- 10198459273513
- 40198459273514
- 10195327640422
- 40195327640423
- 10195327456757
- 40195327456758
- 10198459191640
- 40198459191641
- 10193489611977
- 40193489611978
- 10193489874594
- 40193489874595
- Lot code
- 25DME064
- 25HMD841
- 25JMD489
- 25KME329
- 25KMH848
- 25LMC029
- 25LMH235
- 25LMK305
- DYNJ901922G
- 24KBP812
- DYKM1417I
- 24DLA405
- 24ELA912
- 24GLA871
- 24ILA151
- 24JLA326
- DYKM1417J
- 25BLA761
- 25BLA886
- 25DLA353
- 25ELA056
- 25FLA429
- 25HLA196
- 25HLA242
- 25KLA388
- 25KLA610
- DYNJ58146A
- 23KDA851
- 24ADC096
- 24CDB107
- 24DDB887
- 24IDA855
- 24JDB494
- 24LDA691
- 25BMF825
- 25DMD969
- 25FMC760
- 25GMD422
- DYNDA2138A
- UDI-DI
- 10195327501259
- 40195327501250
- 10195327371029
- 40195327371020
- Lot code
- 24DBW065
- 24EBV301
- 24HBB492
- 24JBW143
- 25ABG413
- 25CBH359
- 25DBD213
- 25GBP569
- 25HBQ088
- 25KBF725
- 26ABE643
- 24FBM018
- 24GBL319
- UDI-DI
- 10198459606397
- 40198459606398
- 10195327479473
- 40195327479474
- 10198459237270
- 40198459237271
- 10884389857700
- 40884389857701
- 10889942212491
- 40889942212492
- 10198459245695
- 40198459245696
- 10198459305030
- 40198459305031
- 10198459478253
- 40198459478254
- 10195327391706
- 40195327391707
- 10198459452703
- 40198459452704
- 10195327145330
- 40195327145331
- 10195327171469
- 40195327171460
- 10193489986815
- 40193489986816
- 10195327415174
- 40195327415175
- 10195327509941
- 40195327509942
- 10195327596569
- 40195327596560
- 10193489468052
- 40193489468053
- Lot code
- 25LBR616
- DYNJ900898G
- 23JBI824
- 23KBJ535
- 24ABR789
- 24ABV917
- 24BBU610
- 24DMK530
- 24FMF039
- 24GME122
- 24JMB670
- 24KMH657
- 25AMA403
- 25BME938
- DYNJ901922I
- 25BBL628
- 25FBM655
- 25HBW072
- 25KBO230
- DYNJ38313B
- 24BBR676
- 24CBF032
- 24FBD924
- 24JBE567
- 25EBA277
- 25FBO580
- 25IBI418
- DYNJ32750G
- 23KME954
- 23LMD492
- 24BMF722
- 24FMH267
- 24HMC509
- DYNJ32750I
- 25BMA765
- 25DMC474
- 25EMI991
- 25IME718
- 26AMJ190
- DYNJ911252
- 25EBU007
- 25LBC286
- 25LBI365
- 26ABC803
- 26ABU372
- DYNJ58146B
- 25HMG837
- 25JMJ636
- 26AMJ160
- DYNJ902016K
- 23JBL313
- 23KBX206
- 24ABG361
- 24ABS317
- 24CBU624
- 24DBT777
- 24EBP517
- 24IBB815
- 24LBH029
- 24LBK316
- 25BBD830
- 25BBK993
- 25DBQ241
- 25DBR926
- DYNJ902016L
- 25HBV912
- 25IBT298
- 25KBT137
- DYNJ908686
- 23LBG479
- DYKE1859
- 23LBU165
- 24ABT730
- 24CBL345
- 24FBK106
- 24HBJ512
- 25DBS024
- 25EBL346
- DYNJ901666L
- 24DDC241
- 24EDB399
- DYNJ908777A
- 23JBV709
- 23KBC057
- 23LBP026
- 23LBP071
- 23LBP286
- 24BBH036
- 24DBD851
- 24FBC615
- 24GBH920
- 24HBS270
- 24KBL822
- 25ABE547
- 25BBP040
- 25BBR359
- 25CBA577
- DYNJ900482N
- 23KDB600
- 24ADA178
- DYNJ900482O
- 24CDA456
- 24EDC051
- 24GDB830
- 24IDB049
- 24JDB140
- 24KDA731
- 25ADB869
- 25BDA267
- 25CMD906
- DYNJ907605
- 23JBA743
- 23JBI519
- 23LBQ647
- 24ABX014
- 24BBQ594
Thoracic Robots, DYNJ908777B
- UDI-DI
- 10198459269196
- 40198459269197
- Lot code
- 25EBD732
- 25GBG733
- 25IBQ613
- 25JBD457
- 25KBT352
- 26ABA235
- 26ABP735
Airway Exam Kit, DYKE1796
- UDI-DI
- 10193489874716
- 40193489874717
- Lot code
- 24CBT023
- 24FBB701
- 24LBL343
- 25GBP141
Medline convenience kits containing Olympus biopsy valves
- UDI-DI
- 10198459629334
- 40198459629335
- 10198459545283
- 40198459545284
- 10195327471859
- 40195327471850
- Lot code
- 26AMG895
- 25LBJ366
- 26ABR365
- 24EBA317
- 24EBV431
- 24IBD694
- 24JBQ783
Medline Anterior Hip Pack DYNJ64672B
- UDI-DI
- 10195327377496
- 40195327377497
- Lot code
- 23LMD300
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Montana, New York, Ohio, Pennsylvania, Tennessee, Texas.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Foreign object
- 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
- 98530
- Recall numbers
- Z-1705-2026 to Z-1711-2026
All recalls from Medline Industries, LP
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
Summary updated
