Open Accessibility Menu

Ethicon Surgical Staple Recall

Wagner Reese

Surgical staplers are medical devices used to close up wounds or connect tissues. They are used as a substitute for stitches. Surgical staples are considered quicker, easier, and uniform, and may be used internally for organs. However, as use of surgical staples have grown, so have the number of surgical complications.

On Friday May 17, 2019, the FDA issued a Class I recall for a stapler made by Ethicon. A Class I recall is the highest-level recall because of risk of severe injury or death.

This latest recall is one of many red flags involving surgical staples. The FDA is currently reviewing the safety of surgical staples. The FDA plans to issue draft guidance for internal surgical use of staples and labeling information in the coming months. However, in the course of reviewing the safety of surgical staples, the number of possible complications the FDA identified with the use of surgical staples is staggering. Since 2011 there have been 41,000 adverse medical device reports including 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.

A review of the massive amounts of adverse event reports make it clear that defective staples might be linked to many health-related issues including:

  • Bleeding
  • Fistula formation
  • Sepsis
  • Tearing of internal organs and tissues
  • Increased risk of cancer recurrence
  • Death

If you or a loved one had a medical procedure between Jan. 1, 2011 - March 31, 2018 and experienced complications due to surgical staples, please call the law firm of Wagner Reese.


Request Your Free Case Evaluation

Fill out the form below to get started or give us a call at (888) 204-8440 to speak with our legal team directly.

  • Please enter your First Name.
  • Please enter your Last Name.
  • This isn't a valid phone number.
    Please enter your phone number.
    You entered an invalid number.
  • This isn't a valid email address.
    Please enter your email address.
  • Please make a selection.
  • Please enter a message.

Our Locations

  • Indianapolis Office: 201 N. Illinois St.,
    16th Floor - South Tower

    Indianapolis, IN 46204
  • Carmel Office: 11939 N. Meridian St.
    Carmel, IN 46032
  • Evansville Office: 815 John St. Suite 110
    Evansville, IN 47713
  • Fort Wayne Office: 3201 Stellhorn Rd
    Fort Wayne, IN 46815
  • Champaign Office: 701 Devonshire Dr., Suite C17
    Champaign, IL 61820