{"recall":{"id":"fda-device-99250","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"AVID Medical, Inc. recalls Halyard STANDARD LINE INSERTION PACK","firm":"AVID Medical, Inc.","date":"2026-05-19","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.","code":"Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).","quantity":"112 kits","number":"Z-2772-2026","classification":"Class II"}],"reason":"Defects in the silicone seal, which may result in \"doming\" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the state of California.","nationwide":true,"states":[],"units":"112 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=99250","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ae3356184203b7ab","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=99250","record":[{"status":"Ongoing","city":"Toano","state":"VA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99250","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":"U.S. Nationwide distribution in the state of California.","recall_number":"Z-2772-2026","product_description":"Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01.     Convenience kit.","product_quantity":"112 kits","reason_for_recall":"Defects in the silicone seal, which may result in \"doming\" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.","recall_initiation_date":"20260519","center_classification_date":"20260722","report_date":"20260729","code_info":"Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026)."}]}}