Z-3289-2026

Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602...

Name: Z-3289-2026 Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602...
Creator: American Nitrile Operations Llc
Published: 2026-08-14
License: https://open.fda.gov/license/

American Nitrile Operations Llc / initiated 2026-08-14 / Open, Classified

FDA source

Recall record

Recall number: Z-3289-2026
Status: Open, Classified
Initiated: 2026-08-14
Posted: 2026-09-25
Recalling firm: American Nitrile Operations Llc
Product: 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
Product code: LZA Polymer 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.
FDA root cause: Process control
Action: Firm began notifying its VA customers on August 15, 2026 via email. Instruction to Customers: 1. Immediately cease all use of the affected products. 2. Notify all users throughout your facility of the product recall. 3. Examine your inventory and immediately quarantine the affected lots to avoid accidental use 4 Contact distributor for replacement.
Quantity in commerce: 99,724,000
Distribution: US Nationwide distribution.
Product codes and lots: 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

Product code LZA

K220825Class ISapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC / cleared 2022-07-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)