Integra LifeSciences Corp.: Medical Device Recall in 2023 - (Recall #: Z-0548-2024)

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:

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

Product Classification:

Class I

Date Initiated: October 5, 2023

Date Posted: December 20, 2023

Recall Number: Z-0548-2024

Event ID: 93084

Reason for Recall:

Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

Status: Ongoing

Product Quantity: 4941

Code Information:

UDI-DI 10381780520665 All lots distributed

Distribution Pattern:

US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL GA IA KY LA MA ME MN ND NE NH NJ NY OK PA RI TN TX UT VA WI WV OUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.

Voluntary or Mandated:

Voluntary: Firm initiated