Integra¿ Cranial access kit — Class II medical device recall Z-1873-2024
Ongoing recall by Integra LifeSciences Corp., reported 2024-05-29, distributed nationwide. Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the s
| Recall number | Z-1873-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-04-17 |
| Classified | 2024-05-20 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,822 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780263906 |
| Lot numbers | 7257032, 7275713, 7289690, 7291974, 7291975, 7312131, 7312137, 7312139 |
| Model numbers | INS5HND |
Product
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Reason for recall
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise 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-1873-2024. 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.