CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report

Integra¿ Cranial Access Kit-For access to the subarachnoid recalled

Integra LifeSciences is recalling Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral, distributed nationwide in the US. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI:10381780431947 Lot Number/Exp. Date: 6788735 1-Mar-25 7078240 1-May-25

Quantity recalled180 units

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-0494-2024
FDA event ID: 93356
Recalling firm: Integra LifeSciences, Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 19 Oct 2023
FDA classified: 6 Dec 2023
Reported: 13 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

19 Oct 2023	Recall initiated by company
6 Dec 2023	Classified by FDA	+48 days
13 Dec 2023	Published in enforcement report	+7 days

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

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

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

Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI-DI:10381780431947 Lot Number/Exp. Date: 6788735 1-Mar-25 7078240 1-May-25

Where was it sold?

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

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.

Other products in this recall event

8 other products · FDA event 93356

This product is part of a recall event; the main page for the event is Integra Cranial Access Kit - For access to the subarachnoid recalled.

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023	CLASS II	Integra Cranial Access Kit - For access to the subarachnoid recalled	Integra LifeSciences	Sterility	Nationwide
13 Dec 2023	CLASS II	Integra Cranial access kit (without Prep solutions) Bit recalled	Integra LifeSciences	Sterility	Nationwide
13 Dec 2023	CLASS II	Integra Cranial Access Kit-For access to the subarachnoid recalled	Integra LifeSciences	Sterility	Nationwide
13 Dec 2023	CLASS II	Integra¿ Cranial Access Kit-For access to the subarachnoid recalled	Integra LifeSciences	Sterility	Nationwide
13 Dec 2023	CLASS II	Integra Cranial Access Kit -For access to the subarachnoid recalled	Integra LifeSciences	Sterility	Nationwide
13 Dec 2023	CLASS II	Integra Cranial Access Kit-For access to the subarachnoid recalled	Integra LifeSciences	Sterility	Nationwide
13 Dec 2023	CLASS II	Integra Cranial Access Kit- For access to the subarachnoid recalled	Integra LifeSciences	Sterility	Nationwide
13 Dec 2023	CLASS II	Combo Kit Consists OF 10-110/Ins-4500/Ins-7040- For access recalled	Integra LifeSciences	Sterility	Nationwide

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