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Ethicon Endo-Surgery Inc recalls ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte
Recalled February 7, 2024 · FDA recall Z-0834-2024 · Ethicon Endo-Surgery
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. · FDA Class II
Units
22,616 (US), 4,476 (OUS)
Sold at
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Description
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.
Product
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
Manufacturer(s)
Ethicon Endo-Surgery Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →