Inspira AIR Balloon Dilation System 10x40 recall
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Why was Inspira AIR Balloon Dilation System 10x40 recalled?
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
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 No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
- Product
- INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of TX, MT, AL & OK.
- Recall date
- May 14, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)