Reported Jan 14, 2026 · Ongoing
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the…
Integra LifeSciences Corp. (NeuroSciences)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. (NeuroSciences) · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- Codman CereLink ICP Sensor Basic Kit
- Catalog Number826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only
- Lot codes and dates
- Catalog Number826850
- UDI-DI10381780520672
- Lot Numbers
217 of 217 codes
726195872666917266692728806072938377293836730604073060417306042730604373060447306045730604673060477306050730605173060527307670730767173076727325482730767573254817325483732548473076737307674732548573254867336611733661273366147336623733661373366157336616733661873366197336620733662173366227306048730604973366267336627733662973471667336628734629573462977346299734630173654347365435739201973966077396608739660973966107392034
- Amount recalled
- 5,116 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
This product could cause temporary or reversible health problems — stop using it.
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