Integra LifeSciences Corp.: Medical Device Recall in 2023 - (Recall #: Z-0498-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04

Product Classification:

Class II

Date Initiated: October 19, 2023

Date Posted: December 13, 2023

Recall Number: Z-0498-2024

Event ID: 93356

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

Status: Ongoing

Product Quantity: 173 units

Code Information:

UDI-DI: 10381780263869 Lot Number/Exp. Date: 6788615 1-Dec-23; 7002983 1-Jan-24

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated