Integra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
- Recall date
- April 4, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1724-2025
- FDA classification
- Class II
- Brand / firm
- Integra LifeSciences Corp. (NeuroSciences)
- Sold / distributed
- US Nationwide distribution in the states of TX, MT, AL & OK.
Why it was recalled
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
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