FDA recall Z-1723-2025

Product

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

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-04-07

Report date

2025-05-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1723-2025