FDA-Device2025-05-14Class II
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Ambu Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Affected count
160 units
Manufactured in
6721 Columbia Gateway Dr Ste 200, N/A, Columbia, MD, United States
Products
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1723-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief