Recall Z-1723-2025
Ambu Inc. · initiated April 7, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Codes / lots: Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1723-2025
- Initiated
- April 7, 2025
- Posted by FDA
- May 6, 2025
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Quantity
- 160 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
- Recalling firm
- Ambu Inc., Columbia, MD