Integra LifeSciences Corp. (NeuroSciences): Device Recall

Recall #Z-1037-2026 · 12/12/2025

Class II: Risk

Recall Details

Recall Number: Z-1037-2026
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp. (NeuroSciences)
Status: Ongoing
Date Initiated: 12/12/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,116 units

Reason for Recall

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

Product Description

Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. 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.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia (Plurinational State of), Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, France, Georgia, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Kenya, Korea (the Republic of), Lithuania, Nepal, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).

Other Recalls by Integra LifeSciences Corp. (NeuroSciences)

Class II: Risk 12/12/2025

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Class II: Risk 10/03/2025

It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Class I: Dangerous 09/26/2025

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class I: Dangerous 09/26/2025

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class II: Risk 08/05/2025

Packaging failures were identified which could lead to a breach in the sterile barrier.

View all recalls by Integra LifeSciences Corp. (NeuroSciences) →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.