FDA-Device2025-05-14Class II
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Hazard
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Sold states
US Nationwide distribution in the states of TX, MT, AL & OK.
Affected count
6 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1724-2025More Integra LifeSciences Corp. (NeuroSciences) recalls
- FDA-Device2026-05-20Integra Codman CerebroFlo EVD Catheter recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix 2-Layer recalled for high endotoxin levels
- FDA-Device2026-04-22Integra Cytal Burn Matrix recalled for elevated endotoxin levels
- FDA-Device2026-04-22Integra Cytal Wound Matrix recalled for elevated endotoxin levels
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