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SunMed Tracheal Tube, Size 2.5 recallZ-3172-2026 · Well Lead Medical CO. Ltd · initiated Jul 31, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Well Lead Medical CO. Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The 6Fr suction catheter could not pass through the samples smoothly.

FDA root cause category: Process control

What the company is doing

On 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.

Recall details

Recall number
Z-3172-2026
Status
Open, Classified
Initiated by the company
Jul 31, 2026
Posted by the FDA
Sep 15, 2026
Recalling firm
Well Lead Medical CO. Ltd
Quantity
27200
Product code
BTR
FDA submissions
K042683
Distribution
US Nationwide distribution in the state of MI.

Product description

SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25

Code information (models, lots, serial numbers)

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;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

25 devices cleared under K042683 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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