American Nitrile Blue Nitrile Patient Examination Gloves
Blue Nitrile Patient examination gloves may have tears, missing fingers, and debris, which can expose people to infectious pathogens or chemical agents.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
American Nitrile Operations LLC recalled certain blue nitrile patient examination gloves, including Opportunity Flex, Opportunity Pro, and Performance Pro, because the gloves may exhibit defects such as tears, missing fingers, and debris.
Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities. The recall began August 14, 2026, and was added to the FDA's Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
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?
3 products
Affected if its UDI-DI, lot code and model/catalog number are listed under that product.
Opportunity Flex
- UDI-DI
- 818634025517
- 818634025449
- 818634025456
- 818634025463
- 818634025470
- Model/Catalog number
- 72-50900
- 72-50901
- 72-50902
- 72-50903
- 72-50904
- Lot
- AO01292
- AO01356
- AO01430
- AO01457
- 72-RM50901
- AO01357
- AO01431
- AO01458
- 72-RM50902
- AO01274
- AO01351
- AO01355
- AO01426
- AO01427
- AO01429
- AO01448
- AO01456
- AO01377
- AO01384
- AN250511407
- AN250211237
- AN250411331
- AN250211252
- AN250211236
- 72-RM50903
- AO01309
- AO01346
- AO01353
- AO01385
- AO01396
- AO01425
- AN250511332
- 72-RM50904
- AO01310
- AO01339
- AO01352
- AO01354
- AO01386
- AO01408
- AN250511409
- AN250511333
Opportunity Pro
- UDI-DI
- 818634025487
- 818634025401
- 818634025418
- 818634025425
- 818634025432
- Model/Catalog number
- 72-50800
- 72-50801
- 72-50802
- 72-50803
- 72-50804
- Lot
- AO01519
- 72-RM50801
- AO01518
- AO01564
- 72-RM50802
- AO01517
- AO01531
- AO01530
- AO01568
- 72-RM50803
- AO01529
- AO01567
- AO01593
- AO01594
- 72-RM50804
- AO01222
- AO01528
- AO01566
- AN250310948
- AN250310947
- AN250310945
- AN250311327
Performance Pro
- UDI-DI
- 818634025562
- 818634025579
- 818634025555
- 818634025548
- Model/Catalog number
- 72-RM50601
- 72-RM50602
- 72-RM50603
- 72-RM50604
- Lot
- AO01306
- AO01347
- AO01358
- AO01381
- AO01407
- AO01446
- AO01466
- AO01476
- AO01500
- AO01513
- AO01535
- AO01536
- AO01551
- AO01631
- AO01584
- AO01634
- AN250511319
- AO01307
- AO01348
- AO01359
- AO01379
- AO01388
- AO01398
- AO01410
- AO01452
- AO01467
- AO01477
- AO01501
- AO01514
- AO01533
- AO01534
- AO01552
- AO01582
- AO01667
- AO01525
- AO01532
- AO01563
- AO01585
- AO01668
- AN250511396
- AO01304
- AO01313
- AO01364
- AO01378
- AO01387
- AO01395
- AO01399
- AO01405
- AO01411
- AO01424
- AO01432
- AO01444
- AO01453
- AO01454
- AO01468
- AO01469
- AO01479
- AO01480
- AO01504
- AO01515
- AO01635
- AO01270
- AO01365
- AO01380
- AO01400
- AO01433
- AO01455
- AO01481
- AO01503
- AO01553
- AN250411247
- AN250511398
- AN250511322
Details
- Company began the recall
- Sold in
US Nationwide distribution.
- Event ID
- 99748
- Recall numbers
- Z-3289-2026 to Z-3291-2026
- Company
- American Nitrile Operations LlcGrove City, Ohio
- Hazard
- Contamination
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
