Class II — Integra LifeSciences Corp. (NeuroSciences)
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. |
| Product | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the states of TX, MT, AL & OK. |
| Initiated | 2025-04-04 |
| Classified | 2025-05-06 |
| Recall number | Z-1724-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (NeuroSciences) (Z-1724-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96672/
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