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.

The FDA said it was a class I recall, the most serious category declared only when there is a risk of serious harm or death. The FDA didn’t say whether the injuries and the death were directly caused by the stapler malfunctioning.

Shares of New Brunswick, New Jersey-based J&J were down 0.8 per cent to US$131.74 at 10:02 a.m. in New York.

J&J has been beset by more than 100,000 lawsuits claiming products including opioids, baby powder, surgical devices and drugs harmed patients. The company has defended itself in court and said its products are safe, but the mountain of legal claims against it have begun to concern investors.

The recall applies to 8,256 of J&J’s Echelon Flex Endopath staplers, distributed in August and September in the U.S. A representative for J&J didn’t immediately respond to a request for comment.