BEUDAMED
    FDA Recall Open, Classified

    Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR 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.

    Recall: Z-1036-2026 · Initiated December 12, 2025

    Recall

    Recall Number
    Z-1036-2026
    Event Number
    98091
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    FEI Number
    3003418325
    Product Code
    GWM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 12, 2025
    Posted
    January 8, 2026
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    Description

    Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR 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.

    Reason

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

    Action

    Integra LifeSciences Corporation notified consignees on about 12/12/2025 via FedEx overnight mailing. Consignees were instructed to identify impacted part numbers and lot numbers on hand, remove them immediately from service and quarantine them, complete and return the Acknowledgement Form, and maintain the notice for records. Consignees were also instructed to forward the notification to those who utilize the product for awareness of the recall. Once the Acknowledgement Form is received, and noted that affected product are on hand, Customer Service will contact consignees and provide a Return Material Authorization (RMA) number and directions to return the affected product.

    Distribution

    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).

    Quantity

    1,301 units