Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-R...
FDA Device Recall #Z-3289-2026 - Class II, August 14, 2026
Recall Summary
| Recall Number | Z-3289-2026 |
| 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 | 99,724,000 |
Product Description
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
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-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
Other Recalls from American Nitrile Operations Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3290-2026 | Class II | Brand Name: Opportunity Flex Product Name: Opp... | Aug 14, 2026 |
| Z-3291-2026 | Class II | Brand Name: Opportunity Pro Product Name: Oppo... | 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.