Ethicon Endo-Surgery Inc: Device Recall

Recall #Z-0147-2026 · 09/11/2025

Class II: Risk

Recall Details

Recall Number: Z-0147-2026
Classification: Class II
Product Type: Device
Recalling Firm: Ethicon Endo-Surgery Inc
Status: Ongoing
Date Initiated: 09/11/2025
Location: Blue Ash, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 units

Reason for Recall

The devices were shipped unsterilized.

Product Description

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

Distribution Pattern

International distribution to the countries of United Arab Emirates.

Other Recalls by Ethicon Endo-Surgery Inc

Class I: Dangerous 04/22/2025

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.

View all recalls by Ethicon Endo-Surgery Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.