Recall Z-3172-2026 ยท BTR Tube, Tracheal (W/Wo Connector)
WELL LEAD MEDICAL CO. LTD
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
| Date | Sep 15, 2026 (initiated Jul 31, 2026) |
| Status | Open, Classified |
| 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 o |
| Quantity | 27200 |
| Distribution | US Nationwide distribution in the state of MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042683 | WELL LEAD ENDOTRACHEAL TUBE Well Lead Medical Instruments, Feb 18, 2005 |