{"recall":{"id":"fda-device-99318","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medline Industries, LP recalls 2 products","firm":"Medline Industries, LP","date":"2026-06-10","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267","code":"UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467","quantity":"163 kits","number":"Z-2736-2026","classification":"Class II"},{"name":"Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J","code":"UDI-DI 10195327388447 Kit Lot 26DME172","quantity":"163 kits","number":"Z-2737-2026","classification":"Class II"}],"reason":"Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CA and UT.","nationwide":true,"states":[],"units":"163 kits; 163 kits","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=99318","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"03918326eb164856","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=99318","record":[{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99318","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA and UT.","recall_number":"Z-2736-2026","product_description":"Medline Kits containing Zimmer Biomet mixing bowls and spatulas    TOTAL KNEE PACK  DYNJT6267","product_quantity":"163 kits","reason_for_recall":"Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.","recall_initiation_date":"20260610","center_classification_date":"20260715","report_date":"20260722","code_info":"UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467","more_code_info":""},{"status":"Ongoing","city":"Northfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99318","recalling_firm":"Medline Industries, LP","address_1":"3 Lakes Dr","address_2":"","postal_code":"60093-2753","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of CA and UT.","recall_number":"Z-2737-2026","product_description":"Medline Kits containing Zimmer Biomet mixing bowls and spatulas    TOTAL KNEE PACK-LF  DYNJ61651J","product_quantity":"163 kits","reason_for_recall":"Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.","recall_initiation_date":"20260610","center_classification_date":"20260715","report_date":"20260722","code_info":"UDI-DI 10195327388447 Kit Lot 26DME172","more_code_info":""}]}}