# FDA recall Z-0124-2020

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2019-09-12.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0124-2020
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-09-12
- **Report date:** 2019-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0124-2020

## Citation

> AI Analytics. FDA recall Z-0124-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0124-2020. Source: US FDA. Licensed CC0.

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