This week, the FDA issued a new safety communication about the ShoulderFlex Massager, after receiving reports of adverse events linked to the device, including a fatality and other serious injuries. According to the agency’s warning, The Consumer Safety Products Commission has already received one report of death and another of near strangulation associated with use of the device.

In its safety communication, the FDA noted that injuries associated with use of the massager occurred when clothing or jewelry became caught in the device’s rotating components. The agency has cautioned that both consumers and healthcare professionals not use the device and have also asked that the device’s components, the power supply and massage fingers, be thrown away separately in order to ensure that it cannot be reassembled for use.

King International, the manufacturer of the ShoulderFlex Massager, has sold the device since 2003, and since that time, approximately 12,000 of the massagers have been distributed. The FDA is currently reviewing King International’s plan for a recall of their ShoulderFlex Massager.