Aug. 29, 2011 -- The FDA has issued a safety communication for the ShoulderFlex Massager because of a risk of strangulation, or other serious injury, with the device. The Consumer Safety Products Commission has received reports of one death and another near strangulation, the FDA said.
The fatality and near fatality occurred when clothing or jewelry became caught in the device's rotating component. Two other reports of similar events that involved clothing and hair getting caught in the device were noted in the FDA safety statement.
The FDA is currently evaluating manufacturer King International's plan for a recall of the ShoulderFlex Massager.
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The personal massage unit is made up of a rotating bar that a patient places on a flat surface and reclines on. The device has movable massage "fingers" that can adjust to area and depth, and is packaged with a handheld controller, memory foam pillow, and a sleeve, the statement said.
The FDA cautioned that consumers and healthcare professionals should not use the device or advise patients to use it. The components -- the power supply and massage fingers -- should be thrown out separately so that the device cannot be reassembled and used.
King International has sold the device online and in retail stores since Oct. 18, 2003. Nearly 12,000 ShoulderFlex Massagers have been distributed, according to the FDA statement.