Recall Z-1746-2025— Ethicon Endo-Surgery Inc

Name: FDA recall Z-1746-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-22

Class I · Ongoing

Class I FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2025-04-22. It names one FDA 510(k) clearance: K141952. Product: Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35. Reason: 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..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class I
Status: Ongoing
Initiated: 2025-04-22
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K141952 — ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCEDEthicon Endo-Surgery, Inc.·cleared 2014-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.