Surgical staplers manufactured by Johnson & Johnson’s Ethicon division are the subject of a voluntary Class I recall. The staplers, which are used in the surgical treatment of hemorrhoids and other rectal abnormalities, are being recalled because they are difficult to use and often misfire. When that happens, severe pain, sepsis, bleeding and damage to the rectal canal may occur. The recall affects all Ethicon Proximate HCS Hemorrhoidal Circular Staplers and accessories and Transtar Circular Stapler Procedure Sets manufactured between April 16, 2011, and July 24, 2012.
Devices & Diagnostics Letter