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
- Microsensor Kit
- Model numbers
- Catalog Number: 626631US, UDI-DI: 10381780514473, Lot Numbers: 7288007, 7288040, 7294017, 7305988, 7305989, 7305990 +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 Microsensor Basic Kit is utilized for monitoring intracranial pressure in patients. It plays a crucial role in managing conditions that affect brain pressure, ensuring timely medical interventions.
Why This Is Dangerous
The potential corrosion stains on the Tuohy Needle could compromise its effectiveness, leading to inaccurate pressure readings or increased risk of infection.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act swiftly to avoid potential health risks. Immediate discontinuation of use is critical to ensure safety.
Practical Guidance
How to identify if yours is affected
- Locate the catalog number on the product packaging.
- Check the lot numbers against the recalled list.
- Contact healthcare provider for verification if unsure.
Where to find product info
The catalog number and lot number can typically be found on the product box or the accompanying documentation.
What timeline to expect
Expect the refund or exchange process to take approximately 4 to 8 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Reach out to the FDA or relevant health authorities.
How to prevent similar issues
- Always verify product recalls before use.
- Look for safety certifications when purchasing medical devices.
- Consult healthcare providers about the latest product safety information.
Documentation advice
Keep a record of your purchase details, communication with the manufacturer, and any health issues experienced after using the product.
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Product Details
The recalled Codman Microsensor Basic Kit, catalog number 626631US, is used for direct intracranial pressure (ICP) monitoring. The kit includes a 14-gauge Tuohy Needle and is distributed worldwide.
Key Facts
- Potential corrosion risk
- No reported injuries
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Safety Guide
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