CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Opportunity Pro recalled by American Nitrile Operations
American Nitrile Operations is recalling Opportunity 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-3291-2026
- 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: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove
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-RM50800 UDI-DI 818634025487 Lots AO01519 Item No. 72-RM50801 UDI-DI 818634025401 Lots AO01518 AO01564 Item No. 72-RM50802 UDI-DI 818634025418 Lots AO01517 AO01531 AO01530 AO01568 Item No. 72-RM50803 UDI-DI 818634025425 Lots AO01529 AO01567 AO01593 AO01594 Item No. 72-RM50804 UDI-DI 818634025432 Lots AO01222 AO01528 AO01566 Alternate lots AN250310948, AN250310947, AN250310945, AN250311327
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 99748This product is part of a recall event; the main page for the event is Performance Pro recalled by American Nitrile Operations.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide | |
| CLASS II | Opportunity Flex 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 Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro 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 Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro 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 |