The FDA issued a warning of life-threatening injury in regard to the ShoulderFlex therapeutic massager made by King International LLC that killed one person and nearly strangled another.
The report asks health care providers not to recommend the device and urges consumers to dispose of the device’s pieces separately so that they can’t be reassembled and used. The watchdog agency is evaluating King International’s plans for recall.
"The FDA is concerned that the ShoulderFlex Massager presents serious health risks," according to the warning. "Hair, clothing, and jewelry can become entangled in the massage device and cause serious injury or death."
The device is a personal massager that provides deep tissue massage to the neck, shoulder and back while a user lies on it. It contains a rotating bar with removable "fingers" that can be adjusted to modify the massage.
The incidents leading to the warning and upcoming recall occurred when a necklace and piece of clothing got caught in the device’s rotating massager. The FDA noted that it had two other reports of hair and clothing being caught in the device.
Beaverton, Oreg.-based King distributed nearly 12,000 of the ShoulderFlex massagers through stores and online retailers throughout the U.S. since October 2003.
Click here to view a promotional demonstration of the ShoulderFlex massager. The video advises users to keep hair and jewelry away from the rotating bar.