# FDA recall Z-0548-2024

> **Integra LifeSciences Corp.** · Class I · device recall initiated 2023-10-05.

## Product

CereLink ICP Extension Cable (Extension Cable), Model No. 826845    Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

## Reason for recall

Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

## Distribution

US distribution nationwide to the following states:  AL  AR  AZ  CA  CO  CT  DC  DE  FL  GA  IA  KY  LA  MA  ME  MN  ND  NE  NH  NJ  NY  OK  PA  RI  TN  TX  UT  VA  WI  WV   OUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.

## Key facts

- **Recall number:** Z-0548-2024
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-05
- **Report date:** 2023-12-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0548-2024

## Citation

> AI Analytics. FDA recall Z-0548-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0548-2024. Source: US FDA. Licensed CC0.

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