{"recall":{"id":"fda-device-99527","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls 7 products","firm":"AVID Medical, Inc.","date":"2026-07-09","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27","code":"Lot Code: Lot Number: 1634391 UDI: 10809160439708","quantity":"45 kits","number":"Z-3005-2026","classification":"Class II"},{"name":"Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03","code":"Lot Code: Lot Number: 1632948 UDI: 10809160423578","quantity":"63 kits","number":"Z-3006-2026","classification":"Class II"},{"name":"Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03","code":"Lot Code: Lot Number: 1649979 UDI: 10809160457887","quantity":"78 kits","number":"Z-3007-2026","classification":"Class II"},{"name":"Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03","code":"Lot Code: Lot Number: 1654575 UDI: 10809160457887","quantity":"78 kits","number":"Z-3008-2026","classification":"Class II"},{"name":"Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03","code":"Lot Code: Lot Number: 1662335 UDI: 10809160457887","quantity":"120 Kits","number":"Z-3009-2026","classification":"Class II"},{"name":"Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03","code":"Lot Code: Lot Number: 1673233 UDI: 10809160457887","quantity":"130 KITS","number":"Z-3010-2026","classification":"Class II"},{"name":"Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03","code":"Lot Code: Lot Number: 1649519 UDI: 10809160457887","quantity":"78 kits","number":"Z-3011-2026","classification":"Class II"}],"reason":"Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of MS, TX.","nationwide":true,"states":[],"units":"45 kits; 63 kits; 78 kits; 78 kits; 120 Kits; 130 KITS; 78 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=99527","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"6423febdf0e28ff8","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=99527","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99527","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont 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to identify that the statlock component contains natural rubber latex.","recall_initiation_date":"20260709","center_classification_date":"20260821","report_date":"20260902","code_info":"Lot Code: Lot Number: 1673233 UDI: 10809160457887"},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99527","recalling_firm":"AVID Medical, Inc.","address_1":"9000 Westmont Dr","address_2":"N/A","postal_code":"23168-9351","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of MS, TX.","recall_number":"Z-3011-2026","product_description":"Halyard TOTAL JOINT  Model/Catalog Number: MSBM036-03","product_quantity":"78 kits","reason_for_recall":"Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.","recall_initiation_date":"20260709","center_classification_date":"20260821","report_date":"20260902","code_info":"Lot Code: Lot Number: 1649519 UDI: 10809160457887"}]}}