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Johnson & Johnson is recalling a surgical stapler after reports that seven patients were seriously injured and one died, the U.S. Food and Drug Administration said Thursday.

The device, made by J&J’s Ethicon unit, is used to simultaneously cut and staple tissue back together during surgery. But problems with a part caused misformed staples that failed to properly close incisions, the FDA said in a statement, leading to potential leakage, bleeding or more surgery.

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