FDA designates Class I recall for disposable surgical stapler cartridge correction

Editor's Note

The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death.

As detailed in the agency’s July 25 announcement,  the recall affects reloads used with the Echelon Flex Powered Vascular Stapler. Ethicon is reportedly correcting this product due to the potential for inadvertent instrument lockout during surgery, in which the device may momentarily activate but fail to cut or staple tissue. This requires additional steps to open the device and remove it from tissue. Risks include life-threatening hemorrhage, surgical delay, and death.

As of April 22, 2025, there has been one reported death and one reported injury associated with this issue. See the FDA announcement for identifying information, instructions for users, a video demonstration on managing device lockouts, and additional details.