{"recall":{"id":"fda-device-99813","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"GRI Medical & Electronic Technology Co., Ltd. recalls HALYARD Laparoscopy Comprehensive Pack II REF: 49332","firm":"GRI Medical & Electronic Technology Co., Ltd.","date":"2026-08-26","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"HALYARD Laparoscopy Comprehensive Pack II REF: 49332","code":"UDI-DI: 10680651493320 (unit level), 30680651493324 (case level) Lot Numbers: GL25271CXA-Expiry Date: 2029/3/30; GL25296CXA-Expiry Date: 2029/3/30; GL26076CXA-Expiry Date: 2029/5/31","quantity":"396 kits","number":"Z-0077-2027","classification":"Class II"}],"reason":"Laparoscopy packs labeled as \"latex free\" were found to contain a latex urethral catheter","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of MS.","nationwide":true,"states":[],"units":"396 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=99813","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"75e083e8863baee1","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=99813","record":[{"status":"Ongoing","city":"Jia Xing","state":"N/A","country":"China","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99813","recalling_firm":"GRI Medical & Electronic Technology Co., Ltd.","address_1":"1805 Honggao Road","address_2":"Nanhu District","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of MS.","recall_number":"Z-0077-2027","product_description":"HALYARD Laparoscopy Comprehensive Pack II  REF: 49332","product_quantity":"396 kits","reason_for_recall":"Laparoscopy packs labeled as \"latex free\" were found to contain a latex urethral catheter","recall_initiation_date":"20260826","center_classification_date":"20261002","report_date":"20261014","code_info":"UDI-DI: 10680651493320 (unit level), 30680651493324 (case level) Lot Numbers: GL25271CXA-Expiry Date: 2029/3/30; GL25296CXA-Expiry Date: 2029/3/30; GL26076CXA-Expiry Date: 2029/5/31"}]}}