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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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.

The Hazard

The recall addresses potential corrosion stains on the surface of the Tuohy needle, which may compromise safety during medical procedures. Corrosion could lead to device malfunction or ineffective pressure monitoring.

Reported Incidents

No injuries or deaths have been reported related to this issue. The recall is classified as Class II, indicating a potential risk of serious injury.

What to Do

Patients and healthcare providers should stop using the ICP Sensor Basic Kit immediately. Contact Integra LifeSciences Corp. or your healthcare provider for specific instructions on the recall.

Contact Information

For further assistance, contact Integra LifeSciences Corp. at their official website or customer service number.

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.

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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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