updated 12/4/2009 2:22:20 PM ET 2009-12-04T19:22:20

The Food and Drug Administration says doctors and hospitals should stop using a device from Steris Corp. to sterilize surgical tools after reports of malfunction.

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The agency says the company's modified SS1 sterilizer device has not been cleared as safe and effective. Users have reported problems that could result in patients becoming infected from unsterile instruments.

The agency recommends physicians begin using alternative devices as soon as possible.

The FDA warned Mentor, Ohio-based Steris in May 2008 about the problems with its devices, and the company was supposed to begin transitioning customers to alternative products.

The agency says: "FDA is not satisfied that the firm has been working effectively to transition its customers."

Steris did not immediately return a call for comment Friday afternoon.

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