Lower riskMedical device recall · FDA · Published June 22, 2022
Integra CereLink ICP Monitor: ICP Readings May Drift Out of Range
Integra recalls CereLink ICP monitors with catalog numbers 826820 and 826820P due to potential ICP readings drifting to -50 mmHg, which could trigger error messages.
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
Integra is recalling CereLink ICP monitors that may show incorrect intracranial pressure readings as low as -50 mmHg. This could cause the device to display an error message about sensor failure, potentially leading to inaccurate health monitoring. Read more at govinfonow.com/recall/60470-integra-cerelink-icp-monitor-icp-readings-may-drift-out-of.
“Integra CereLink ICP Monitor: ICP Readings May Drift Out of Range.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60470-integra-cerelink-icp-monitor-icp-readings-may-drift-out-of. Based on FDA recall #Z-1395-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1395-2022%22&limit=1).
Integra LifeSciences Corp. recalled the CereLink ICP Monitor worldwide on June 22, 2022, according to the FDA. The intracranial pressure monitor may display inaccurate readings or error messages due to electrical interference.
How to tell if you have it
Brand: Integra
Product: CereLink ICP Monitor
Catalog No.: 826820, 826820P
UDI-DI: 10381780533778
All serial numbers
The hazard
Integra has received complaints associated with ICP readings drifting to -50 mmHg and may manifest an error message "sensor or extension cable failure!" The firm found this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Other recent recalls include the AURORA Surgiscope System recall (Feb. 6, 2025), MediHoney Wound Dressing Gel recall (Jan. 10, 2025), and CODMAN CERTAS Plus Valve recall (Dec. 16, 2024). Other recent recalls of similar products include the Codman CereLink ICP Sensor Basic Kit recall (Dec. 12, 2025), Sophysa Pressio 2 ICP Monitor reboots recall (Nov. 17, 2025), and Codman Microsensor Basic Kit recall (Dec. 12, 2025).
How to tell if you have this one
Check for catalog numbers 826820 or 826820P on the monitor. The device is sold as an intracranial pressure monitor with a unique serial number.
Brand
Integra
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Monitor Readings
Look for error messages like "sensor or extension cable failure!" or unusually low ICP readings.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days 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-1395-2022 (June 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1395-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.