FDA Device recall Z-0124-2020
Cerelink ICP Monitor, Model Number 826820
- FDA Device
- Class II
- ongoing
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class II recall of Cerelink ICP Monitor, Model Number 826820 by Integra Lifesciences, citing there is a potential for a progressive decline in observed ICP readings of the monitor during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0124-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-12 |
| Published | 2019-10-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra Lifesciences |
| Distribution | CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, WV |
Product
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Reason
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Identifiers
| code_info | All systems |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0124-2020%22
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