Recall Z-0834-2024— Ethicon Endo-Surgery Inc

Name: FDA recall Z-0834-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-11

Class II · Ongoing

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2023-12-11. It names one FDA 510(k) clearance: K163454. 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. Reason: 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..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-12-11
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K163454 — ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mmEthicon Endo-Surgery, LLC·cleared 2017-01-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.