The U.S. Food and Drug Administration wants consumers and health professionals to know about serious health risks posed by the ShoulderFlex Massager.
The FDA is aware of reports to the U.S. Consumer Product Safety Commission of one death and one near-strangulation associated with the massager.
The incidents occurred when a necklace and clothing became caught in a piece of the device that rotates during use. Two other reports involved clothing and hair that became caught in the massager.
The ShoulderFlex Massager, distributed by King International, is a personal massage device designed for home use to provide deep tissue massage to the neck, shoulder, and back while the user lies on a flat surface.
King International has distributed 11,934 massagers since October 2003. The devices were sold at various stores and online retailers in the United States.
The FDA advises consumers not to use the ShoulderFlex Massager and store it safely, the agency said in a statement. The agency is evaluating King International’s plan for a recall of the massager, which may lead to additional action by the FDA or King International. Return information for consumers may become available at that time.