Recall of Device Recall Electrosurgical pencil

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

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 2
  • 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
    Electrosurgical, cutting; coagulation & accessories - Product Code GEI
  • Reason
    Electrosurgical pencil may remain activated or self activate after power switch is released.
  • Action
    Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138.


  • Model / Serial
    Lot code range: 0903253 through 1002143
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico, Saudi Arabia, Spain, Taiwan.
  • Product Description
    ClearVac Goldline Rocker Switch with UltraClean Blade Electrode, REF 60-6829-005A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.
  • Manufacturer


  • Manufacturer Address
    ConMed Electrosurgery, 14603 E Fremont Ave, Centennial CO 80112-4251
  • Manufacturer Parent Company (2017)
  • Source