# FDA recall Z-0491-2024

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2023-10-19.

## 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

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia,  Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.

## Key facts

- **Recall number:** Z-0491-2024
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-19
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0491-2024

## Citation

> AI Analytics. FDA recall Z-0491-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0491-2024. Source: US FDA. Licensed CC0.

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