Recall Z-1723-2025 · EOQ Bronchoscope (Flexible Or Rigid)
Ambu Inc.
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
| Date | May 6, 2025 (initiated Apr 7, 2025) |
| Status | Open, Classified |
| Reason | Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8. |
| Root cause | Process control |
| Action | Ambu notified sales representative first on 04/07/2025 with an "Urgent Field Safety Notice" letter and they are instructed to visit the affected accounts to notify them of the recall. The letter instructs customers to identify and quarantine any affected units on hand, to arrange for the return of affected units or destroy them on site, and to complete and return the response form. |
| Quantity | 160 units |
| Distribution | US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set Ambu A/S, Sep 20, 2023 |