HIGH

Integra LifeSciences Recalls ICP Sensor Kit Over Corrosion Risk

Integra LifeSciences Corp. recalled 5,116 units of the Codman CereLink ICP Sensor Basic Kit on December 12, 2025. The recall stems from potential corrosion stains on the included 14-gauge Tuohy needle. Healthcare providers and patients must stop using the device immediately and follow the recall instructions.

Quick Facts at a Glance

Recall Date
December 12, 2025
Hazard Level
HIGH
Brand
Integra LifeSciences Corp.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Codman CereLink ICP Sensor Basic Kit is designed for monitoring intracranial pressure in patients requiring such medical assessment. It includes a specialized sensor and needle for direct access to cranial areas.

Why This Is Dangerous

The corrosion on the needle can lead to a risk of infection or inadequate pressure monitoring, which is critical in neurological assessments.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires immediate action from healthcare providers to ensure patient safety, as continued use could jeopardize monitoring accuracy.

Practical Guidance

How to identify if yours is affected

  1. Check the catalog number on the product packaging or documentation.
  2. Verify the lot numbers against the recalled list.
  3. Contact the manufacturer if there is any uncertainty.

Where to find product info

Lot numbers and catalog numbers can be found on the product packaging or the instruction manual.

What timeline to expect

Expect a realistic timeline of 4-6 weeks for refunds or replacements once your request is processed.

If the manufacturer is unresponsive

  • Document all correspondence with the manufacturer.
  • Reach out again using different contact methods.
  • Consider filing a complaint with regulatory bodies if unresponsive.

How to prevent similar issues

  • When purchasing medical devices, verify certification and safety records.
  • Always check for recalls and safety notices before use.
  • Consult healthcare providers for recommendations on reliable products.

Documentation advice

Keep records of any communications with the manufacturer and maintain copies of receipts and recall notices.

Product Details

The Codman CereLink ICP Sensor Basic Kit, catalog number 826850, includes a nylon tube with a pressure transducer and a 14-gauge Tuohy needle. The kit is used for intracranial pressure monitoring and is compatible with the Codman Cranial Hand Drill. It is distributed worldwide, including the U.S. and several countries.

Key Facts

  • Recall date: December 12, 2025
  • Report date: January 14, 2026
  • Total units recalled: 5,116
  • Class II recall
  • Worldwide distribution including the U.S.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIntracranial Pressure Monitoring Device
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number: 826850
UDI-DI: 10381780520672
Lot Numbers: 7261958
7266691
7266692
+17 more
Affected States
ALL
Report Date
January 14, 2026
Recall Status
ACTIVE

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