Integra Cerelink ICP Monitor Recall: Potential Decline in Pressure Readings
Integra LifeSciences recalls Cerelink ICP Monitor model 826820 due to potential progressive decline in observed ICP readings during use. Affected users should contact the company for details.
Lower-risk recall
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Contact the company
What happened, in plain English
Integra LifeSciences is recalling its Cerelink ICP Monitor model 826820 because it may show decreasing pressure readings over time. This could lead to inaccurate medical monitoring, which is serious for patients using the device. Read more at govinfonow.com/recall/67024-integra-cerelink-icp-monitor-recall-potential-decline-in-pressure-readings.
Source Summary by GovInfoNow · govinfonow.com/recall/67024-integra-cerelink-icp-monitor-recall-potential-decline-in-pressure-readings · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0124-2020
Cite this page
“Integra Cerelink ICP Monitor Recall: Potential Decline in Pressure Readings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67024-integra-cerelink-icp-monitor-recall-potential-decline-in-pressure-readings. Based on FDA recall #Z-0124-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0124-2020%22&limit=1).
Why it’s dangerous
The monitor may show progressively lower readings over time, which could result in inaccurate blood pressure or fluid pressure measurements. This might lead to incorrect medical decisions if the device is used for critical monitoring.
Who’s affected
Patients using the Cerelink ICP Monitor for medical pressure monitoring are most at risk. The device is intended for use with specific medical systems.
How to tell if you have this one
Check for the model number 826820 on the Cerelink ICP Monitor. The device is intended for use as an interface between pressure transducers and medical monitoring systems.
- Brand
Integra LifeSciences- Category
Medical device
What to do — step by step
Check Device Model
Look for the model number 826820 on the Cerelink ICP Monitor.
Where it went and when
Where it was distributed
Distributed in 11 states, and outside the U.S.
FDA distribution: “The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Connecticut, Florida, Indiana, New York, Oklahoma, Pennsylvania, Texas, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device safe to use?
The device may show decreasing readings over time, which could affect accuracy, but the recall record does not indicate immediate danger.
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Where this comes from
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-0124-2020 (September 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0124-2020 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.