{"recall":{"id":"fda-device-99685","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"WELL LEAD MEDICAL CO. LTD recalls SunMed Tracheal Tube","firm":"WELL LEAD MEDICAL CO. LTD","date":"2026-07-31","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25","code":"Model Number: 1-7333-25; UDI-DI:10889483048108; Lot No.: 2108011462, 2108011506, 2109011963, 2111012039, 2112012040, 2204010568, 2204010569, 2204010734, 2205010833, 2207011263, 2208011729, 2208011789, 2304010830, 2306011372, 2306011425, 2308011907, 2308012011, 2308012012, 2309012128, 2310012358, 2310012599, 2311013016, 2311012924, 2312013223, 2401010069, 2401010197, 2402010378, 2403010466, 2403010889, 2404010999, 2406011822, 2407012282, 2408012389, 2409012800, 2409012882, 2508013006, 2510013653, 2511014081, 2512014080, 2602010272, 2603010274, 2603010900, 2604011014, 2604011416, 2605011923, 2605011924;","quantity":"27200","number":"Z-3172-2026","classification":"Class II"}],"reason":"The 6Fr suction catheter could not pass through the samples smoothly.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of MI.","nationwide":true,"states":[],"units":"27200","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=99685","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"6686f7e7c407e1dc","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=99685","record":[{"status":"Ongoing","city":"Guangzhou","state":"N/A","country":"China","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99685","recalling_firm":"WELL LEAD MEDICAL CO. LTD","address_1":"NO. 47 Guomao Avenue South , Panyu","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the state of MI.","recall_number":"Z-3172-2026","product_description":"SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25","product_quantity":"27200","reason_for_recall":"The 6Fr suction catheter could not pass through the samples smoothly.","recall_initiation_date":"20260731","center_classification_date":"20260915","report_date":"20260923","code_info":"Model Number: 1-7333-25; UDI-DI:10889483048108; Lot No.: 2108011462, 2108011506, 2109011963, 2111012039, 2112012040, 2204010568, 2204010569, 2204010734, 2205010833, 2207011263, 2208011729, 2208011789, 2304010830, 2306011372, 2306011425, 2308011907, 2308012011, 2308012012, 2309012128, 2310012358, 2310012599, 2311013016, 2311012924, 2312013223, 2401010069, 2401010197, 2402010378, 2403010466, 2403010889, 2404010999, 2406011822, 2407012282, 2408012389, 2409012800, 2409012882, 2508013006, 2510013653, 2511014081, 2512014080, 2602010272, 2603010274, 2603010900, 2604011014, 2604011416, 2605011923, 2605011924;","more_code_info":""}]}}