Summary
The FDA issued a Class II for Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US by Ambu Inc.. Reason: 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 incorre.
Details
Source
Device Recall
External ID
Z-1723-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Lot/Code Info: Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Quantity Affected: 160 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-07
Company
Columbia, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ambu Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ambu Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ambu Inc. have FDA actions?
Ambu Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1723-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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