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Disposable Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address an Inadvertent Lockout During Surgical Procedures

The FDA is aware that Ethicon Endo-Surgery, LLC has sent all affected customers an Urgent Medical Device Correction letter for its Endopath Echelon Vascular White Reload for Advanced Placement Tip. The letter provides instructions to correct an inadvertent lockout during surgical procedures.  Using the affected product without the correction may cause serious adverse health consequences, including life-threatening hemorrhage, surgical delay, and death.

Ethicon Endo-Surgery, LLC has reported one death and one injury related to this issue.

This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Questions?

Customers in the U.S. with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).