Device recall
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
- Recall number
- Z-3172-2026
- Event id
- 99685
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- WELL LEAD MEDICAL CO. LTD
- Report date
- Sep 23, 2026
- Posted
- Sep 15, 2026
- Initiated
- Jul 31, 2026
- Center classification date
- Sep 15, 2026
- Product code
- BTR
- Device type
- Tube, Tracheal (W/Wo Connector)
- Reason
- The 6Fr suction catheter could not pass through the samples smoothly.
- Root cause
- Process control
- Quantity
- 27200
- 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;
- Distribution
- US Nationwide distribution in the state of MI.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K042683
- Location
- Guangzhou, N/A, China