Class II U.S. Food and Drug Administration

American Nitrile Operations Llc Brand Name: Opportunity Flex Product Name recall: Gloves may exhibit defects such as tears, missing fingers

Recall published 18 days ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3290-2026
Published
October 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
American Nitrile Operations Llc
Product type
Medical devices
Units affected
36,793,000
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
818634025517, 818634025449, 818634025456, 818634025463, 818634025470

Products covered by this recall

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

Check your product

The notice names 16 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 818634025517
  • 818634025449
  • 818634025456
  • 818634025463
  • 818634025470

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AN250511407
  • AN250211237
  • AN250411331
  • AN250211252
  • AN250211236
  • AN2502

Model or item number

On the rating label, the box or the instruction sheet.

  • 72-50900
  • 72-50901
  • 72-50902
  • 72-50903
  • 72-50904 Pr

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

American Nitrile Operations Llc — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: American Nitrile Operations Llc — 3500 Southwest Blvd, Grove City, OH, 43123-2244

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was American Nitrile Operations Llc medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 818634025517, 818634025449, 818634025456; lot code AN250511407, AN250211237, AN250411331; model number 72-50900, 72-50901, 72-50902. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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