Reported May 28, 2025 · Ongoing
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ethicon Endo-Surgery Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803
Is this the product you have?
- Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
- Lot codes and dates
- UDI-DI
- GTIN 10705036014591 Packaging Batches
917C65895C93918C15938C92936C69929C38948C78990C81979C81400D82962C74506D29379D80413D56418D41419D47415D43427D07434D35442D78442D83444D96456D87455D03493D27468D88482D30502D90489D62134D80112D03155D33159D49181D11194D77125D04167D13223D59175D72234D11238D70261D10270D69317D74194D76349D54347D73317D73356D54326D66319D76338D99336D39356D53367D26378D04214D17
- Amount recalled
- 678,526
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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