Recall of Device Recall LICOX C8.B temperature probe, Model 160504 and 240604

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra Neuro Sciences.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Test, Sorbent, Fta-Abs - Product Code GMW
  • Reason
    Licox model c8.B temperature probes manufactured by gms mbh, an integra company, may exhibit progen (endotoxin) levels above the fda limit of 2.15 endotoxin units per device. elevated endotoxin levels may result in an increased patient risk of fever.
  • Action
    LICOX Model C8.B temperature probes and LICOX IM3.ST Complete Brain IMC Probe Kits manufactured by GMS mbH, an Integra company, may exhibit pyrogen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.


  • Model / Serial
    Lot numbers: 160504 and 240604
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    LA, CA, CO, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, NE, NY, OH, OR, PA, SD, TN, TX, VA
  • Product Description
    LICOX temperature probe, Model C8.B
  • Manufacturer


  • Manufacturer Address
    Integra Neuro Sciences, 5955 Pacific Center Blvd, San Diego CA 92121-4309
  • Source