Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set recall: Labeling Error
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Why was Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
- Product
- Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Recalling firm
- Ambu Inc.
- Quantity
- 160 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
- Recall date
- May 14, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)