{"recall":{"id":"fda-device-99808","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls 15 products","firm":"AVID Medical, Inc.","date":"2026-08-10","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;","code":"1. Model/Item Number (Kit): SAMM064-27; UDI-DI: 10809160439708; Kit Lot Numbers: 1657586, 1658104, 1671251; 2. Model/Item Number (Kit): SAMM064-28; UDI-DI: 10809160516201; Kit Lot Numbers: 1698700; Recalled Supplier Component (in kit): A303416A; Recalled Supplier Lot Number (in kit): NGKU1749, NGKV0359;","quantity":"144","number":"Z-0092-2027","classification":"Class II"},{"name":"GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;","code":"1. 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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=99808","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2c625d41e74c70e4","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=99808","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99808","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":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.","recall_number":"Z-0092-2027","product_description":"DAVINCI TRUCUSTOM BUNDLE;  Model/Item Number (Kit): 1. 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Model/Item Number (Kit): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943;  Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391;"},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99808","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":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.","recall_number":"Z-0097-2027","product_description":"PACK OPEN HEART CFH;  Model/Item Number (Kit): 1. UFCF004-06, 2. 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 Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT3314;"},{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99808","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":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.","recall_number":"Z-0106-2027","product_description":"ABD HYSTERECTOMY;  Model/Item Number (Kit): NAMC438-07;","product_quantity":"23","reason_for_recall":"Product may be potentially contaminated with a lubricant used during the manufacturing process.","recall_initiation_date":"20260810","center_classification_date":"20261007","report_date":"20261014","code_info":"Model/Item Number (Kit): NAMC438-07; UDI-DI: 10809160417645; Kit Lot Numbers: 1675123, 1675125, 1679551;  Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404;"}]}}