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Ethicon Issues Class I Recall for Surgical Staplers
On October 3rd Johnson & Johnson subsidiary Ethicon issued a Class 1 recall for over 8,200 Echelon Flex 60 Articulating Endoscopic Linear Cutters, more commonly known as surgical staplers. Class 1 is the most serious type of recall and indicates that lives are at stake.
Surgical Staplers Implicated in 9,000 Injuries and Over 350 Deaths
Surgical staplers are commonly used by surgeons as a substitute for sutures for the purpose of closing lacerations or incisions as well as connecting or removing internal organs, such as the lungs or lower intestines. These devices have been used for over 50 years – and have been the subject of more than 41,000 adverse event reports submitted to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.