FDA recall Z-3172-2026
WELL LEAD MEDICAL CO. LTD · Class II · device
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.
Distribution
US Nationwide distribution in the state of MI.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-07-31
- Report date
- 2026-09-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Guangzhou, N/A, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3172-2026