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U.S. Department of Health and Human Services

Class 2 Device Recall SunMed Tracheal tube (size 2.5)

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 Class 2 Device Recall SunMed Tracheal tube (size 2.5)see related information
Date Initiated by FirmJuly 31, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3172-2026
Recall Event ID 99685
510(K)NumberK042683 
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
ProductSunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Code Information 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;
FEI Number 3010400865
Recalling Firm/
Manufacturer		 WELL LEAD MEDICAL CO. LTD
NO. 47 Guomao Avenue South , Panyu
Guangzhou China
For Additional Information ContactBin Chen
+86 20 84758878
Manufacturer Reason
for Recall		The 6Fr suction catheter could not pass through the samples smoothly.
FDA Determined
Cause 2		Process control
ActionOn July 31, 2026 URGENT: MEDICAL DEVICE RECALL letters were emailed to customers. Actions to be taken: 1. We request that you check your inventory for product within the scope of this recall. Quarantine all impacted product immediately. Cease use and distribution immediately. 2. If the affected product is currently in use on a patient, do not perform a prophylactic endotracheal tube exchange solely due to this notification. Continue to manage the patient according to institutional protocols and clinical judgment. 3. If you do have stock in scope of this recall, mark the applicable checkbox on the Affected Product Information Table and contact Well Lead by E-mail . 4. If you do not have stock in scope of this recall, mark the applicable checkbox on the Affected Product Information Table and return the form to the E-mail address . 5. For affected products, please contact your distributor to arrange product replacement.
Quantity in Commerce27200
DistributionUS Nationwide distribution in the state of MI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BTR
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