(WASHINGTON) -- The ShoulderFlex Massager, sold by King International in stores since 2003, poses a risk of serious injury and even death, according to the FDA. The agency has issued a safety warning for the device, for which the Consumer Safety Products Commission has received reports of near strangulation and a death, MedPage Today reports. Other reports included hair and clothing becoming snagged in the massager.
The device has adjustable massaging fingers that can be controlled with a handheld controller. Users recline back on the ShoulderFlex when it is placed on a flat surface.
The FDA advised consumers and health care professionals not to use the ShoulderFlex or suggest that patients use it. The FDA also suggested users dispose of the massaging fingers and power supply separately from the unit so that it cannot be reassembled and used again.
An FDA assessment is now underway of King International's plan for recalling the device.
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