Recall of Device Recall EpiFix

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, 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
    Epidural catheter fixation device. - Product Code KMK
  • Reason
    Sterility of some units may be compromised due to damaged packaging.
  • Action
    Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.


  • Model / Serial
    Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide, including USA, France, Germany, and United Kingdom.
  • Product Description
    EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
  • Manufacturer


  • Manufacturer Address
    Merit Medical Systems, Inc, 1600 West Merit Pkwy, South Jordan UT 84095-2416
  • Source