Device recall
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
- Recall number
- Z-3291-2026
- Event id
- 99748
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- American Nitrile Operations Llc
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 14, 2026
- Center classification date
- Sep 25, 2026
- Product code
- LZA
- Device type
- Polymer Patient Examination Glove
- Reason
- 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.
- Root cause
- Process control
- Quantity
- 17,481,000
- Code 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
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K220825
- Location
- Grove City, OH, United States