CereLink ICP Extension Cable — Class I medical device recall Z-0548-2024
Ongoing recall by Integra LifeSciences Corp., reported 2023-12-20, distributed nationwide. Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereL
| Recall number | Z-0548-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2023-10-05 |
| Classified | 2023-12-14 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Quantity | 4,941 |
| UPC / GTIN / UDI-DI | 10381780520665 |
| Model numbers | 826820/826820P, 826845 |
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.
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-0548-2024. 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.