FDAFDA recall Z-3172-2026 · Sep 23, 2026
WELL LEAD MEDICAL CO. LTD: SunMed Tracheal Tube recall
Recall found
Product
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Reason for recall
The 6Fr suction catheter could not pass through the samples smoothly.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Distribution
- US Nationwide distribution in the state of MI.
- Recalling firm
- WELL LEAD MEDICAL CO. LTD, Guangzhou, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-31
Source: openFDA enforcement record Z-3172-2026 · search recall number Z-3172-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.