Before Upclassification By FDA, Ethicon Recalled Faulty Surgical Staplers

Surgical stapler manufacturer Ethicon initiated a recall on April 11 of two of its staplers used in gastrointestinal tract surgeries, FDA announced on Thursday (May 16). The recall was initiated shortly before FDA decided to upclassify surgical staplers and staples from Class I to Class II after receiving tens of thousands of adverse events related to the devices. FDA said uncut washers in the staplers and malformed staples occurred due to insufficient firing in the staplers, which can compromise staple...