The Natus Cranial Access Kit is designed to be a complete — Class II medical device recall Z-0735-2023
Ongoing recall by Natus Medical Incorporated, reported 2022-12-28, distributed nationwide. Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being
| Recall number | Z-0735-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, San Diego, CA, United States |
| Recall initiated | 2022-11-18 |
| Classified | 2022-12-20 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 249 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00382830048590, 00382830048620, 00382830048637 |
| Lot numbers | 22GDB675, 22HDA557, 22IDB724 |
| Model numbers | HITH1 |
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.
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-0735-2023. 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.