Integra LifeSciences Corp.: Medical Device Recall in 2024 - (Recall #: Z-1873-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

Product Classification:

Class II

Date Initiated: April 17, 2024

Date Posted: May 29, 2024

Recall Number: Z-1873-2024

Event ID: 94453

Reason for Recall:

Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

Status: Ongoing

Product Quantity: 1,822 units

Code Information:

UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of CA, BE, CL.

Voluntary or Mandated:

Voluntary: Firm initiated