- Recalling firm
- WELL LEAD MEDICAL CO. LTD
- Reason for recall
- The 6Fr suction catheter could not pass through the samples smoothly.
- Affected products (lot / model / serial)
- 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;
- Units affected
- 27200
- Distribution pattern
- US Nationwide distribution in the state of MI.
- Firm location
- Guangzhou, N/A, China
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3172-2026
- Recall initiated
- July 31, 2026
- FDA classification date
- September 15, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99685
- Last updated on HTM Vibe
- September 29, 2026