Class IIOngoing
American Nitrile Operations Llc recalls 3 products
Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- American Nitrile Operations Llc
- 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.
- Hazard
- FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
- Who’s affected
- US Nationwide distribution.
- Where
- Nationwide
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99748…
Products (3)
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves
Codes/lots: Item No. 72-RM50601 UDI-DI 818634025562 Lots AO01306 AO01347 AO01358 AO01381 AO01407 AO01446 AO01466 AO01476 AO01500 AO01513 AO01535 AO01536 AO01551 AO01631 AO01584 AO01634 Alternate Lot AN250511319 Item No. 72-RM50602 UDI-DI 818634025579 Lots AO01307 AO01348 AO01359 AO01359 AO01379 AO01388 AO01398 AO01410 AO01452 AO01467 AO01477 AO01501 AO01514 AO01533 AO01534 AO01552 AO01582 AO01667 AO01525 AO01532 AO01563 AO01585 AO01668 Alternate Lots AN250511396 AN250511396 AN250511396 Item No. 72-RM50603 UDI-DI 818634025555 Lots AO01304 AO01313 AO01364 AO01378 AO01387 AO01395 AO01399 AO01405 AO01411 AO01Quantity: 99,724,000Recall no. Z-3289-2026Class IIBrand 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
Codes/lots: 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 loQuantity: 36,793,000Recall no. Z-3290-2026Class IIBrand 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
Codes/lots: 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, AN250311327Quantity: 17,481,000Recall no. Z-3291-2026Class II
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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