The U.S. Food and Drug Administration warned of risks of serious injury or death...
FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake
The recall, initiated early April by Ethicon, covers 92,496 surgical staplers and is now labeled as “Class-1” - the strictest form of recall issued by FDA, where use of faulty devices may cause serious injury or death. The staplers, regulated as Class I medical devices that do not require a premarket submission to the FDA, are used by surgeons during gastrointestinal procedures.
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