{"recall":{"id":"fda-device-99968","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls 2 products","firm":"AVID Medical, Inc.","date":"2026-09-08","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.","code":"Model/Catalog Number: SOAH31. UDI-DI: 10809160512890. Lot Code: Lot Number: 1689215. Expiration Date: 11/06/2026.","quantity":"56 kits","number":"Z-0282-2027","classification":"Class II"},{"name":"Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.","code":"Model/Catalog Number: SOAH30. UDI-DI: 10809160520246. Lot Code: Lot Numbers: 1705826, 1705827. Expiration Date: 1/31/2028.","quantity":"80 kits","number":"Z-0283-2027","classification":"Class II"}],"reason":"A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distributor in the state of Arizona.","nationwide":true,"states":[],"units":"56 kits; 80 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=99968","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"58625840bcf88d61","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99968","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99968","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 distributor in the state of Arizona.","recall_number":"Z-0282-2027","product_description":"Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.","product_quantity":"56 kits","reason_for_recall":"A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.","recall_initiation_date":"20260908","center_classification_date":"20261022","report_date":"20261028","code_info":"Model/Catalog Number: SOAH31. UDI-DI: 10809160512890. Lot Code: Lot Number: 1689215.  Expiration Date: 11/06/2026.","more_code_info":""},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99968","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 distributor in the state of Arizona.","recall_number":"Z-0283-2027","product_description":"Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.","product_quantity":"80 kits","reason_for_recall":"A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.","recall_initiation_date":"20260908","center_classification_date":"20261022","report_date":"20261028","code_info":"Model/Catalog Number: SOAH30. UDI-DI: 10809160520246. Lot Code: Lot Numbers: 1705826, 1705827.  Expiration Date: 1/31/2028.","more_code_info":""}]}}