SunMed Tracheal Tube…

Date

Sept. 23, 2026

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Well Lead Medical Co. Ltd

Product

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

Reason

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

Distribution pattern

US Nationwide distribution in the state of MI.

Quantity

27200

Codes and lots

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;

Recall started

July 31, 2026

Device type

Tube, Tracheal (W/Wo Connector)

Root cause (FDA)

Process control

What the company told customers

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 number

Z-3172-2026

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-3172-2026. The agency record governs; check it and the company before acting.