Lower riskMedical device recall · FDA · Published October 5, 2023
Integra CereLink ICP Extension Cable Recall: Out of Range Readings
Integra LifeSciences recalls CereLink ICP Extension Cable Model 826845 due to potential out of range readings. Affected units sold with Codman CereLink ICP monitors.
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.
“Integra CereLink ICP Extension Cable Recall: Out of Range Readings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57152-integra-cerelink-icp-extension-cable-recall-out-of-range-readings. Based on FDA recall #Z-0548-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2024%22&limit=1).
Integra LifeSciences Corp. voluntarily recalled the CereLink ICP Extension Cable, Model No. 826845, due to out-of-range readings that may affect monitoring accuracy. The Food and Drug Administration announced the Class I recall on Oct. 5, 2023.
Used with: Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P
UDI-DI: 10381780520665
Distribution: US nationwide; Australia/New Zealand, Canada, and Europe/Middle East/Africa
The hazard
The recall addresses an issue where the extension cable provides out-of-range readings. This defect is part of an existing recall initiated in June 2022.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Recent brand recalls include the AURORA Surgiscope System recall on Feb. 6, 2025, for a risk of obturator breaking, and the MediHoney Wound Dressing Gel recall on Jan. 10, 2025, involving induction seal packaging risks. Other recent recalls of similar products include the Codman CereLink ICP Sensor Basic Kit recall (Dec. 12, 2025) and the Sophysa Pressio 2 ICP Monitor recall (Nov. 17, 2025).
How to tell if you have this one
Check for the model number 826845 on the extension cable. The cable is used with Codman CereLink ICP monitors (model numbers 826820 or 826820P). All lots distributed.
Brand
Integra LifeSciences
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cable Model
Verify the extension cable model number is 826845.
Contact Manufacturer
Reach out to Integra LifeSciences for further assistance or to confirm if a replacement is needed.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 29 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0548-2024 (October 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0548-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.