Federal officials are ordering the recall of nearly 2,800 machines used to disinfect medical scopes.
They said company violations could lead to patient infections. The Food and Drug Administration said that Custom Ultrasonics must recall all of its endoscope reprocessing devices, which are currently used in hospitals and medical clinics throughout the U.S. The devices are intended to kill bacteria and microorganisms found on flexible endoscopes after hospital procedures, so that they can be reused safely. But the Warminster, Pa.based manufacturer has a history of violating federal rules for manufacturing and quality control.