CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report

The Natus Cranial Access Kit is designed to be a complete recalled

Natus Medical is recalling The Natus Cranial Access Kit is designed to be a complete, single use and disposable, distributed nationwide in the US. The recall was initiated on 18 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: HITH1 UDI-DI Code: 382830048590 Lot Number: 22GDB675 Part Number: HITHNDRZR UDI-DI Code: 382830048620 Lot Number: 22HDA557 Part Number: HITHLT UDI-DI Code: 382830048637 Lot Number: 22IDB724

Quantity recalled249 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0735-2023
FDA event ID: 91193
Recalling firm: Natus Medical, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Nov 2022
FDA classified: 20 Dec 2022
Reported: 28 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Spinal Implants

Timeline

18 Nov 2022	Recall initiated by company
20 Dec 2022	Classified by FDA	+32 days
28 Dec 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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).

Where it was distributed

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.

Nationwide Alaska California Connecticut District of Columbia Florida Georgia Iowa Idaho Illinois Kansas Maryland Michigan Montana North Dakota Nebraska New Jersey Nevada New York Ohio Oregon

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number: HITH1 UDI-DI Code: 382830048590 Lot Number: 22GDB675 Part Number: HITHNDRZR UDI-DI Code: 382830048620 Lot Number: 22HDA557 Part Number: HITHLT UDI-DI Code: 382830048637 Lot Number: 22IDB724

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Natus Medical

All 17

Reported	Class	Recall	Company	Reason	Where
10 Jan 2024Device	CLASS II	External Drainage System Collection recalled	Natus Medical	Sterility	Nationwide
10 Jan 2024Device	CLASS II	EDS 3 CSF External Drainage System recalled	Natus Medical	Sterility	Nationwide
19 Jul 2017Device	CLASS II	The Olympic Pasteurmatic recalled by Natus Medical Incorporated	Natus Medical	Other	Nationwide
10 May 2017Device	CLASS II	Second generation neoBLUE LED Phototherapy Light recalled	Natus Medical	Other	Nationwide
21 Dec 2016Device	CLASS II	Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy recalled	Natus Medical	Potency & Assay	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide