Z-3172-2026Class II

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

Name: Z-3172-2026 SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Creator: Well Lead Medical Co. Ltd
Published: 2026-07-31
License: https://open.fda.gov/license/

Well Lead Medical Co. Ltd / initiated 2026-07-31 / Open, Classified

FDA source

Recall record

Recall number: Z-3172-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-31
Posted: 2026-09-15
Recalling firm: Well Lead Medical Co. Ltd
Product: SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The 6Fr suction catheter could not pass through the samples smoothly.
FDA root cause: Process control
Action: 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.
Quantity in commerce: 27200
Distribution: US Nationwide distribution in the state of MI.
Product 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3172-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3172-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-15

Product code BTR

K042683Class IIWell Lead Endotracheal TubeWell Lead Medical Instruments / cleared 2005-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)