Ethicon Endo-Surgery Inc: Device Recall

Recall #Z-1746-2025 · 04/22/2025

Class I: Dangerous

Recall Details

Recall Number
Z-1746-2025
Classification
Class I
Product Type
Device
Recalling Firm
Ethicon Endo-Surgery Inc
Status
Ongoing
Date Initiated
04/22/2025
Location
Blue Ash, OH, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
678,526

Reason for Recall

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.

Product Description

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

Distribution Pattern

US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.

Other Recalls by Ethicon Endo-Surgery Inc

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.