Integra Cranial access kit — Class II medical device recall Z-0491-2024
Ongoing recall by Integra LifeSciences Corp., reported 2023-12-13, distributed nationwide. Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any addition
| Recall number | Z-0491-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-12-06 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, CA, CL, FR, GB, IE, IL, ZA |
| Quantity | 1,639 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780263906 |
| Lot numbers | 6710219, 6788610, 6788611, 6896403, 7073042, 7248999, 7249000 |
| Model numbers | INS5HND |
Product
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
Reason for recall
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
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-0491-2024. 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.