Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments h

Recalled August 25, 2021 · FDA recall Z-2326-2021 · Ethicon Endo-Surgery

Hazard

Mislabeled: Labeled on the package as 60mm contains 45mm devices · FDA Class II

Units

763 eaches

Sold at

Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.

Description

Mislabeled: Labeled on the package as 60mm contains 45mm devices

Product

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A

Manufacturer(s)

Ethicon Endo-Surgery Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →