CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report

Opportunity Flex recalled by American Nitrile Operations

American Nitrile Operations is recalling Opportunity Flex, distributed nationwide in the US. The recall was initiated on 14 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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

Quantity recalled36,793,000

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3290-2026
FDA event ID: 99748
Recalling firm: American Nitrile Operations, Grove City, OH
Classification: Class II
Status: Ongoing
Recall initiated: 14 Aug 2026
FDA classified: 25 Sep 2026
Reported: 7 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Masks, Gloves & PPE

Timeline

14 Aug 2026	Recall initiated by company
25 Sep 2026	Classified by FDA	+42 days
7 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99748

This product is part of a recall event; the main page for the event is Performance Pro recalled by American Nitrile Operations.

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026	CLASS II	Performance Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
7 Oct 2026	CLASS II	Opportunity Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide

More recalls from American Nitrile Operations

All 3

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Opportunity Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Performance Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide

Other Masks, Gloves & PPE recalls

All 450

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Opportunity Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Performance Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Adapter for Head Positioning recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide