# FDA recall Z-0735-2023

> **Natus Medical Incorporated** · Class II · device recall initiated 2022-11-18.

## Product

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF).

## Reason for recall

Due to Cranial Access Kits containing recalled sterile surgical drapes.  The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

## Distribution

U.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID, IL, KS , MD, MI, MT, ND, NE, NJ, NV, NY, OH, OR, TX, and WA.

## Key facts

- **Recall number:** Z-0735-2023
- **Recalling firm:** Natus Medical Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-18
- **Report date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2023

## Citation

> AI Analytics. FDA recall Z-0735-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0735-2023. Source: US FDA. Licensed CC0.

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