Class II — Integra LifeSciences Corp.
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a potential for a progressive decline in observed ICP readings of the monitor during use. |
| 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. |
| Quantity | 189 |
| 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. |
| Initiated | 2019-09-12 |
| Classified | 2019-10-12 |
| Recall number | Z-0124-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-0124-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83831/
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