Cerelink ICP Monitor — Class II medical device recall Z-0124-2020
Ongoing recall by Integra LifeSciences Corp., reported 2019-10-23, distributed in CA, CO, CT, FL, IN, NY, OK, PA…. There is a potential for a progressive decline in observed ICP readings of the monitor during use.
| Recall number | Z-0124-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2019-09-12 |
| Classified | 2019-10-12 |
| Reported by FDA | 2019-10-23 |
| Distributed | CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, WV |
| Countries outside the US | AU, BE |
| Quantity | 189 |
| Model numbers | 826820 |
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 for recall
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0124-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.