🔍 RecallPedia

ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A

Class I - Dangerous
🏥 Medical Devices Recalled: October 3, 2019 Ethicon Endo-Surgery Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: T9408M, T94899, T94A9Z
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ethicon Endo-Surgery Inc
Reason for Recall:
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A

Product Codes/Lot Numbers:

Lot: T9408M, T94899, T94A9Z

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0200-2020

Related Recalls

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Ethicon Endo-Surgery

Class I - Dangerous

Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

Apr 22, 2025 Other Medical Devices Nationwide View Details →