Z-3291-2026

Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800...

Name: Z-3291-2026 Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800...
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-3291-2026
Status: Open, Classified
Initiated: 2026-08-14
Posted: 2026-09-25
Recalling firm: American Nitrile Operations Llc
Product: 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
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: 17,481,000
Distribution: US Nationwide distribution.
Product codes and lots: 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

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)