Recall of Device Recall Fixed Tip Electrosurgical Electrode.

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

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 tip may break or come off during use.
  • Action
    Customers were notified beginning 6/15/2004 by phone or visit.


  • Model / Serial
    Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
  • Product Description
    AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
  • Manufacturer


  • Manufacturer Address
    Encision, Inc., 4828 Sterling Dr, Boulder CO 80301-2350
  • Source