Z-3289-2026 Class II Ongoing
FDA device recall Z-3289-2026 was initiated by American Nitrile Operations Llc on Aug 14, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 99,724,000.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 14, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3289-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026