Recall Z-3172-2026— WELL LEAD MEDICAL CO. LTD

Name: FDA recall Z-3172-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Class II · Ongoing

Class II FDA medical device recall by WELL LEAD MEDICAL CO. LTD, initiated 2026-07-31. It names one FDA 510(k) clearance: K042683. Product: SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25. Reason: The 6Fr suction catheter could not pass through the samples smoothly..

Recalling firm: WELL LEAD MEDICAL CO. LTD
Classification: Class II
Status: Ongoing
Initiated: 2026-07-31
Firm location: Guangzhou, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K042683 — WELL LEAD ENDOTRACHEAL TUBEWell Lead Medical Instruments·cleared 2005-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.