FDA Medical devices recall ·
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set recall
- Recall number
- Z-1723-2025
- Date
- (initiated April 7, 2025)
- Company / brand
- Ambu
6721 Columbia Gateway Dr Ste 200, Columbia, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 160 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Distribution
US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
States: California Colorado Florida Georgia Kentucky Maryland Montana New Jersey Nevada Pennsylvania Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1723-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.