Brand Name: Opportunity Pro recallZ-3291-2026 · American Nitrile Operations Llc · initiated Aug 14, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from American Nitrile Operations Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-3291-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 14, 2026
- Posted by the FDA
- Sep 25, 2026
- Recalling firm
- American Nitrile Operations Llc
- Quantity
- 17,481,000
- Product code
- LZA
- FDA submissions
- K220825
- Distribution
- US Nationwide distribution.
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 information (models, lots, serial numbers)
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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Bosma Enterprises 72-50801Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50802Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50803Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50804Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50800Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99748).
- Z-3289-2026 · Open, ClassifiedBrand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination g…
- Z-3290-2026 · Open, ClassifiedBrand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examina…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page