{"recall":{"id":"fda-device-99761","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls Halyard IV START KIT NON-STERILE","firm":"AVID Medical, Inc.","date":"2026-07-22","reported":"2026-09-30","status":"Ongoing","classification":"Class I","products":[{"name":"Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.","code":"Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027","quantity":"288 kits (6 cases)","number":"Z-3194-2026","classification":"Class I"}],"reason":"Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"288 kits (6 cases)","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=99761","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b05bfe9157c92745","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=99761","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99761","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.","recall_number":"Z-3194-2026","product_description":"Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator.  Kit Model Number: KRIV26-02.","product_quantity":"288 kits (6 cases)","reason_for_recall":"Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.","recall_initiation_date":"20260722","center_classification_date":"20260923","report_date":"20260930","code_info":"Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027","more_code_info":""}]}}