Massage Tool Poses Risks

US health regulators have cautioned the public that massages delivered by the ShoulderFlex Massager device could be fatal.

The agency urges people who own the device to “dispose of the device components separately so that the massager cannot be reassembled and used”.
The company plans to recall the device, said the FDA

Federal regulators are warning that problems with ShoulderFlex Massagers have been linked to reports of strangulations and at least one death.

The FDA issued a safety communication on August 25, indicating that the design of King International’s ShoulderFlex Massager could cause serious and potentially life-threatening injuries.

The ShoulderFlex Massager is a deep tissue personal massage device designed to massage the shoulder, neck and back. The FDA is asking any consumers who experience an adverse event while using a Shoulder Flex to report those problems to MedWatch, the FDA’s adverse event reporting program.

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 fatality and near fatality occurred when clothing or jewelry became caught in the device's rotating component. The FDA cautioned that consumers and healthcare professionals should not use the device or advise patients to use it. 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.