Recall of Device Recall Disposable AEM Cord

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
    Firm found pinholes in packaging which would compromise sterility.
  • Action
    Affected customers were notified by fax or mail on 7/15/2004.


  • Model / Serial
    REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
  • Product Description
    Encision ES4107 Disposable AEM Cord, Sterile.
  • Manufacturer


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