FDA recalls two unapproved medical devices

WASHINGTON, Dec. 16 (UPI) -- The U.S. Food and Drug Administration announced the recall of two potentially dangerous unapproved medical devices.

The FDA said its "Class 1" recall means there is a reasonable probability the use of the devices manufactured by VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles will cause adverse health consequences or death.

"These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process."

The federal agency said VIBE Technologies marketed the Vibrational Integrated Bio-photonic Energizer, claiming it could treat cancer, infections and depression. Nebion, the FDA said, failed to obtain marketing approval or clearance for its "HLX8" device, which the company said can treat cancer, migraines, arthritis and ruptured discs.

The FDA said neither company demonstrated their devices were safe and effective at curing or treating diseases as claimed.