Duraform Dural Graft Implant — Class II medical device recall Z-0262-2025
Ongoing recall by Integra LifeSciences Corp., reported 2024-11-06. Out of specification endotoxin levels.
| Recall number | Z-0262-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-09-26 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Countries outside the US | CN |
| Quantity | 128 units |
| Reason classes | sterility, specification failure |
| UPC / GTIN / UDI-DI | 10886704079477 |
| Lot numbers | CT007694 |
| Model numbers | 80-1477US |
Product
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Reason for recall
Out of specification endotoxin levels.
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-0262-2025. 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.