Ambu aScope 5 Broncho (Ambu) – Incorrect Labeling (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Brand
Ambu Inc.
Lot Codes / Batch Numbers
Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Products Sold
Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Ambu Inc. is recalling Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US due to 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 incorre. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026