FDA Medical Device Recalls (openFDA)
WELL LEAD MEDICAL CO. LTD: SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
- Recall number
- Z-3172-2026
- Recalling firm
- WELL LEAD MEDICAL CO. LTD
- Product
- SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
- Status
- Open, Classified
- Initiated
- 2026-07-31
- Posted
- 2026-09-15
- Terminated
- not on file
- Reason
- The 6Fr suction catheter could not pass through the samples smoothly.
- 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
- 27200
- Distribution
- US Nationwide distribution in the state of MI.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- K042683
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 3010400865
- Firm city
- Guangzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28