Edition:
United States

Ethicon Recalls Circular Staplers For Insufficient Firing, Failure To Completely Form Staples


Friday, 17 May 2019 10:28am EDT 

May 17 (Reuters) - FDA::ETHICON RECALLS CIRCULAR STAPLERS FOR INSUFFICIENT FIRING AND FAILURE TO COMPLETELY FORM STAPLES.U.S. FDA SAYS FDA HAS IDENTIFIED ETHICON'S RECALL OF CIRCULAR STAPLERS AS A CLASS I RECALL.FDA SAYS ETHICON CONFIRMED SERIOUS INJURIES TO TWO PATIENTS.U.S. FDA SAYS CIRCULAR STAPLER DEVICES RECALLED IN THE U.S. ARE 92,496 UNITS.U.S. FDA SAYS ETHICON CONFIRMED UNCUT WASHERS IN STAPLER & MALFORMED STAPLES OCCUR WITH THEIR INTRALUMINAL CIRCULAR STAPLERS DUE TO INSUFFICIENT FIRING.FDA SAYS RECALLED PRODUCTS INCLUDED ENDO-SURGERY CURVED INTRALUMINAL STAPLER WITH ADJUSTABLE HEIGHT STAPLES.FDA SAYS RECALLED PRODUCTS INCLUDED ENDO-SURGERY ENDOSCOPIC CURVED INTRALUMINAL STAPLER WITH ADJUSTABLE HEIGHT STAPLES.