CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Performance Pro recalled by American Nitrile Operations
American Nitrile Operations is recalling Performance Pro, distributed nationwide in the US. The recall was initiated on 14 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3289-2026
- FDA event ID
- 99748
- Recalling firm
- American Nitrile Operations, Grove City, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Aug 2026
- FDA classified
- 25 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Masks, Gloves & PPE
Timeline
| 14 Aug 2026 | Recall initiated by company | |
| 25 Sep 2026 | Classified by FDA | +42 days |
| 7 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Item No. 72-RM50601 UDI-DI 818634025562 Lots AO01306 AO01347 AO01358 AO01381 AO01407 AO01446 AO01466 AO01476 AO01500 AO01513 AO01535 AO01536 AO01551 AO01631 AO01584 AO01634 Alternate Lot AN250511319 Item No. 72-RM50602 UDI-DI 818634025579 Lots AO01307 AO01348 AO01359 AO01359 AO01379 AO01388 AO01398 AO01410 AO01452 AO01467 AO01477 AO01501 AO01514 AO01533 AO01534 AO01552 AO01582 AO01667 AO01525 AO01532 AO01563 AO01585 AO01668 Alternate Lots AN250511396 AN250511396 AN250511396 Item No. 72-RM50603 UDI-DI 818634025555 Lots AO01304 AO01313 AO01364 AO01378 AO01387 AO01395 AO01399 AO01405 AO01411 AO01424 AO01432 AO01444 AO01453 AO01454 AO01468 AO01469 AO01479 AO01480 AO01504 AO01515 AO01635 Item No. 72-RM50604 UDI-DI 818634025548 Lots AO01270 AO01365 AO01380 AO01400 AO01433 AO01455 AO01481 AO01503 AO01553 Alternate lots AN250411247, AN250511398, AN250511322
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99748| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide | |
| CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
More recalls from American Nitrile Operations
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
Other Masks, Gloves & PPE recalls
All 450| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |