Class II
Medical Device Recall: INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Integra LifeSciences Corp. (NeuroSciences) · April 4, 2025
Reason for Recall
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Distribution
US Nationwide distribution in the states of TX, MT, AL & OK.
States Affected
NATIONWIDE
Quantity Affected
6 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1724-2025
Status: ongoing
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