SunMed Tracheal Tube
The tracheal tube has a suction catheter that may not pass through smoothly.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
WELL LEAD MEDICAL CO. LTD of Guangzhou, China, began a recall of the SunMed Tracheal Tube, Size 2.5, Model Number: 1-7333-25, on July 31, 2026. The FDA added the recall to its Enforcement Report and classified it on September 15, 2026. The agency stated that the 6Fr suction catheter could not pass through the samples smoothly. The product was distributed in Michigan.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
1-7333-25
- UDI-DI
- 10889483048108
- 2108011462
- 2108011506
- 2109011963
- 2111012039
- 2112012040
- 2204010568
- 2204010569
- 2204010734
- 2205010833
- 2207011263
- 2208011729
- 2208011789
- 2304010830
- 2306011372
- 2306011425
- 2308011907
- 2308012011
- 2308012012
- 2309012128
- Lot
- 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
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Michigan.
- Event ID
- 99685
- Recall No.
- Z-3172-2026
- Company
- WELL LEAD MEDICAL CO. LTDGuangzhou, China
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
