Ambu aScope 5 Broncho HD 5 recalled over labeling errors

Recall date

April 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ambu Inc. recalls Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

Recall number

Z-1723-2025

FDA classification

Class II

Brand / firm

Ambu Inc.

Sold / distributed

US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US