{"recall":{"id":"fda-device-99748","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"American Nitrile Operations Llc recalls 3 products","firm":"American Nitrile Operations Llc","date":"2026-08-14","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"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 AO01424 AO01432 AO01444 AO01453 AO01454 AO01468 AO01469 AO01479 AO01480 AO01504 AO01515 AO01635 Item No. 72-RM50604 UDI-DI 818634025548 Lots AO01270 AO01365 AO01380 AO01400 AO01433 AO01455 AO01481 AO01503 AO01553 Alternate lots AN250411247, AN250511398, AN250511322","quantity":"99,724,000","number":"Z-3289-2026","classification":"Class II"},{"name":"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":"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","quantity":"36,793,000","number":"Z-3290-2026","classification":"Class II"},{"name":"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":"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","quantity":"17,481,000","number":"Z-3291-2026","classification":"Class II"}],"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).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"99,724,000; 36,793,000; 17,481,000","remedy":"","whatToDo":"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.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99748","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2a56e6561c80d06e","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99748","record":[{"status":"Ongoing","city":"Grove City","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99748","recalling_firm":"American Nitrile Operations Llc","address_1":"3500 Southwest Blvd","address_2":"","postal_code":"43123-2244","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-3289-2026","product_description":"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","product_quantity":"99,724,000","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.","recall_initiation_date":"20260814","center_classification_date":"20260925","report_date":"20261007","code_info":"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 AO01424 AO01432 AO01444 AO01453 AO01454 AO01468 AO01469 AO01479 AO01480 AO01504 AO01515 AO01635   Item No. 72-RM50604 UDI-DI 818634025548 Lots AO01270 AO01365 AO01380 AO01400 AO01433 AO01455 AO01481 AO01503 AO01553 Alternate lots AN250411247, AN250511398, AN250511322","more_code_info":""},{"status":"Ongoing","city":"Grove City","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99748","recalling_firm":"American Nitrile Operations Llc","address_1":"3500 Southwest Blvd","address_2":"","postal_code":"43123-2244","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-3290-2026","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","product_quantity":"36,793,000","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.","recall_initiation_date":"20260814","center_classification_date":"20260925","report_date":"20261007","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","more_code_info":""},{"status":"Ongoing","city":"Grove City","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99748","recalling_firm":"American Nitrile Operations Llc","address_1":"3500 Southwest Blvd","address_2":"","postal_code":"43123-2244","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-3291-2026","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","product_quantity":"17,481,000","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.","recall_initiation_date":"20260814","center_classification_date":"20260925","report_date":"20261007","code_info":"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","more_code_info":""}]}}