A class 1 recall has been issued for 157,000 surgical devices

The “Medial Tools” being recalled are the Proximate PPH hemorrhoidal circular stapler and accessories, the Proximate HCS hemorrhoidal circular stapler and accessories, and the Transtar circular stapler procedure set.

According to the FDA (Food and Drug Administration) the Johnson & Johnson surgical stapler devices manufactured by the Ethicon Endo-Surgery Division of J&J are being recalled due to difficulty firing, which may result in “failure to complete the firing stroke of the stapler causing severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occulision of the rectal canal,”  which can result in death.

The product HCS (hemorrhoidal circular stapler) which was manufactured between April 2011 and July 2012 had a “lubrication Process Change, that may  potentially impact force-to-fire of the device.” said Johnson & Johnson.  Therefore, the HCS device and its accessories with product code PPH01 have been discontinued in the United States, although the Proximate PPH stapler remains available.

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