CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
SunMed Tracheal Tube, Size recalled by Well Lead Medical
Well Lead Medical is recalling SunMed Tracheal Tube, Size 2.5, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3172-2026
- FDA event ID
- 99685
- Recalling firm
- Well Lead Medical, Guangzhou, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2026
- FDA classified
- 15 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Jul 2026 | Recall initiated by company | |
| 15 Sep 2026 | Classified by FDA | +46 days |
| 23 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The 6Fr suction catheter could not pass through the samples smoothly.
Product as listed by the FDA
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Where it was distributed
US Nationwide distribution in the state of MI.
Questions about this recall
Why was it recalled?
The 6Fr suction catheter could not pass through the samples smoothly.
Which lots are 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;
Where was it sold?
US Nationwide distribution in the state of MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |