Integra LifeSciences Corp.: Medical Device Recall in 2023 - (Recall #: Z-0491-2024)

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 (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

Product Classification:

Class II

Date Initiated: October 19, 2023

Date Posted: December 13, 2023

Recall Number: Z-0491-2024

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: 1639 units

Code Information:

UDI-DI:10381780263906 Lot Number/Exp. Date : 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25

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