SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
FDA Recall Z-3172-2026 · Posted 2026-09-15
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Recalling FirmWELL LEAD MEDICAL CO. LTD
Recall StatusOpen, Classified
Product CodeBTR
Date Initiated2026-07-31
Product Quantity27200
Reason for Recall
The 6Fr suction catheter could not pass through the samples smoothly.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the state of MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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