Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50...
FDA Device Recall #Z-3291-2026 - Class II, August 14, 2026
Recall Summary
| Recall Number | Z-3291-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 14, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Nitrile Operations Llc |
| Location | Grove City, OH |
| Product Type | Devices |
| Quantity | 17,481,000 |
Product Description
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
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.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
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
Other Recalls from American Nitrile Operations Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3289-2026 | Class II | Brand Name: Performance Pro Product Name: Perf... | Aug 14, 2026 |
| Z-3290-2026 | Class II | Brand Name: Opportunity Flex Product Name: Opp... | Aug 14, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.