INSPIRA AIR BALLOON DILATION SYSTEM 10x40 — Class II medical device recall Z-1724-2025
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2025-05-14, distributed nationwide. Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
| Recall number | Z-1724-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2025-04-04 |
| Classified | 2025-05-06 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 20705031063157 |
| Lot numbers | 240716A-PC |
| Model numbers | BC1040AZ |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1724-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.