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Ambu Inc. recalls Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Recalled May 14, 2025 · FDA recall Z-1723-2025 · Ambu
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. · FDA Class II
Units
160 units
Sold at
US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Description
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.
Product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Manufacturer(s)
Ambu Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →