Medical device recalls Moderate risk

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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