FDAFDA · Food and drugs·Recall number Z-0834-2024
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Published February 7, 2024 · Recall initiated: December 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Endo-Surgery Inc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
- Lot
- UDI-DI 10705036014928 Lots 442C02 and 442C03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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