FDA recall Z-1724-2025
Integra LifeSciences Corp. (NeuroSciences) · Class II · device
Product
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.
Distribution
US Nationwide distribution in the states of TX, MT, AL & OK.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-04-04
- Report date
- 2025-05-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Princeton, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1724-2025