{"recall":{"id":"fda-device-99443","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls Halyard LAVH PACK","firm":"AVID Medical, Inc.","date":"2026-07-10","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).","code":"UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027","quantity":"40 packs","number":"Z-2964-2026","classification":"Class II"}],"reason":"The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of TX.","nationwide":true,"states":[],"units":"40 packs","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=99443","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2005ca05f78caf16","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=99443","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99443","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of TX.","recall_number":"Z-2964-2026","product_description":"Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).","product_quantity":"40 packs","reason_for_recall":"The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.","recall_initiation_date":"20260710","center_classification_date":"20260814","report_date":"20260826","code_info":"UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027","more_code_info":""}]}}