Reported May 14, 2025 · Ongoing
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Ambu Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ambu Inc. · 6721 Columbia Gateway Dr Ste 200 · Columbia, MD · 21046-3380
Is this the product you have?
- Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set
- Model Number622002000US
- Lot codes and dates
- Model Number622002000US
- UDI-DI05707480156542
- Lot Number1001080963
- Amount recalled
- 160 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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