SunMed Tracheal Tube recall (WELL LEAD MEDICAL CO. LTD)
Medical deviceClass IIOngoing
Summary: WELL LEAD MEDICAL CO. LTD is recalling SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25. Reason: The 6Fr suction catheter could not pass through the samples smoothly.
What is being recalled
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Why
The 6Fr suction catheter could not pass through the samples smoothly.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of MI. (states named: Michigan)
How to tell if yours is affected
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;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3172-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 31, 2026 |
| Reported | September 23, 2026 |
| Company | WELL LEAD MEDICAL CO. LTD |
| Company location | Guangzhou, N/A, China |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 27200 |
More recalls from WELL LEAD MEDICAL CO. LTD · all medical device recalls · recalls from July 2026