Summary
The FDA issued a Class II for SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 by WELL LEAD MEDICAL CO. LTD. Reason: The 6Fr suction catheter could not pass through the samples smoothly..
Details
Source
Device Recall
External ID
Z-3172-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Lot/Code Info: 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 Affected: 27200
Reason for Recall
The 6Fr suction catheter could not pass through the samples smoothly.
Distribution
US Nationwide distribution in the state of MI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-31
Company
Guangzhou, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
WELL LEAD MEDICAL CO. LTD has 5 FDA actions in our database, including 1 recall and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (WELL LEAD MEDICAL CO. LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WELL LEAD MEDICAL CO. LTD have FDA actions?
WELL LEAD MEDICAL CO. LTD has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3172-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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