The Food and Drug Administration has warned doctors and hospital administrators that a widely used surgical tool sterilizer made by Mentor-based Steris no longer has the agency's "safe and effective" stamp and should not be used.
The product, called System 1, is used to sterilize medical tools such as endoscopes, bronchoscopes and other devices. It is used in hospitals, outpatient surgical centers and some physicians' offices.
Source here.