FDA is issuing a notice to healthcare facility administrators and infection control practitioners that conveys agency concerns about the Steris System 1 Processor (SS1). FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices. FDA is also issuing a letter to STERIS Corporation (STERIS) notifying the firm that FDA may take regulatory action against it regarding the SS1 and its components and accessories.