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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Integra LifeSciences Corp. (NeuroSciences) Medical Device Recall: INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. | SafeCheck