← FDA ENFORCEMENT
Z-3291-2026Class II

American Nitrile Operations Llc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
American Nitrile Operations Llc
Product type
Device
Status
Ongoing
Report date
2026-10-07
Distribution
US Nationwide distribution.
Firm state
OH
Product quantity
17,481,000
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →