• Regulatory NewsRegulatory News

    Another Class I Recall of Ethicon Surgical Staplers, FDA Says

    Following seven serious injuries and one reported death, the US Food and Drug Administration (FDA) announced a Class I recall, the most serious type of recall, of some of Ethicon’s Flex Endopath surgical staplers because they may contain an out of specification component within the jaw of the device that could lead to malformed staples. Ethicon, a subsidiary of Johnson & Johnson (J&J), said that earlier this month it sent a letter to customers who purchased the affected...