Ref No: HITHSP04 / Integra Cranial Access Kit — Class II medical device recall Z-1194-2024
Ongoing recall by Integra LifeSciences Corp., reported 2024-03-06, distributed nationwide. A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integr
| Recall number | Z-1194-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-01-19 |
| Classified | 2024-02-28 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BS, CA, CL, DE, ES, FR, GB, GR, IE, IL, PL, PT, SI, ZA |
| Quantity | 27 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10381780263869 |
| Lot numbers | 7257028 |
| Model numbers | HITHSP04 |
| Expiration dates | 2024-06-01 |
Product
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Reason for recall
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
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-1194-2024. 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.