FDA Device recall Z-1724-2025
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter
- FDA Device
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter by Integra Lifesciences Neurosciences, citing incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1724-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-04 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
Product
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Reason
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Identifiers
| code_info | Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1724-2025%22
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