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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Integra LifeSciences Corp.
- Product type
- Intracranial Pressure Monitoring Device
- Model numbers
- Catalog Number: 826850, UDI-DI: 10381780520672, Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836 +14 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 12, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the catalog number on the product packaging or documentation.
- Verify the lot numbers against the recalled list.
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.