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Ethicon Recalls ECHELON FLEX ENDOPATH Staplers

Ethicon announced the recall of ECHELON FLEX ENDOPATH staplers as some of these devices may contain an out of specification component within the jaw of the device, which could lead to malformed staples. The FDA has identified this as a Class I recall, the most serious type of recall.

As of October 3, 2019, seven serious injuries and one death had been reported to Ethicon for affected product codes.

The Echelon Flex Endopath staplers are used in open or in minimally-invasive surgical procedures to cut and staple internal tissue.

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