INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
FDA Recall #Z-1724-2025 — Class II — April 4, 2025
Product Description
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Reason for Recall
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Recalling Firm
Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6 units
Distribution
US Nationwide distribution in the states of TX, MT, AL & OK.
Code Information
Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated