• 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...
  • J&J Warns Physicians About Counterfeit Medical Device

    • 14 June 2012
    Life sciences manufacturer Johnson & Johnson's subsidiary Ethicon this week warned physicians about counterfeit copies of its Ligaclip Extra Ligating Clip Cartridges, which are used for tubal ligation. The company explained in a "Dear Healthcare Provider Letter" that its investigators had discovered counterfeit copies of the device in at least two countries-the US and Hong Kong-and the company was working with regulatory authorities in both countries to track the sou...
  • J&J Announces Planned Cessation of Vaginal Mesh Sales

    Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the products cause internal bleeding. Bloomberg Businessweek reports the company has requested approval from the US Food and Drug Administration (FDA) to end sales of the product within the next 120 days so consumers and doctors can find alternate suppliers or other treatment op...