FDA Recalls Two Unapproved Medical Devices

The FDA has recalled two unapproved medical devices manufactured by Colorado and California companies, saying they could potentially cause injury or death.

The federal agency said Colorado-based VIBE Technologies marketed the Vibrational Integrated Bio-photonic Energizer, claiming it could treat cancer, infections and depression. California-based 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 showed their devices are safe and effective after warning letters were issued in April.

“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.”