Brand Name: Opportunity Flex recallZ-3290-2026 · 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-3290-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 14, 2026
- Posted by the FDA
- Sep 25, 2026
- Recalling firm
- American Nitrile Operations Llc
- Quantity
- 36,793,000
- Product code
- LZA
- FDA submissions
- K220825
- Distribution
- US Nationwide distribution.
Product description
Brand 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 examination gloves
Code information (models, lots, serial numbers)
Item No. 72-RM50900 UDI-DI 818634025517 Lots AO01292 AO01356 AO01430 AO01457 Item No. 72-RM50901 UDI-DI 818634025449 Lots AO01357 AO01431 AO01458 Item No. 72-RM50902 UDI-DI 818634025456 Lots AO01274 AO01351 AO01355 AO01426 AO01427 AO01429 AO01448 AO01456 AO01377 AO01384 Alternate lots AN250511407, AN250211237, AN250411331, AN250211252, AN250211236, AN250211237, AN250511407 Item No. 72-RM50903 UDI-DI 818634025463 Lots AO01309 AO01346 AO01353 AO01385 AO01396 AO01425 Alternate lot AN250511332 Item No. 72-RM50904 UDI-DI 818634025470 Lots AO01310 AO01339 AO01352 AO01354 AO01386 AO01408 Alternate lots AN250511409, AN250511333
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Bosma Enterprises 72-50901Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50902Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50903Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50904Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Bosma Enterprises 72-50900Bosma 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-3291-2026 · Open, ClassifiedBrand 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 …
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.
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