The FDA is repeating its warning to consumers not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks. The ShoulderFlex Massager is a personal massage device sold in retail stores, catalogs and over the Internet. It is intended to provide users with a deep tissue massage to the neck, shoulders and back area while lying down.
Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation. There have been reports of one death and one near death, due to strangulation, associated with the use of this device.
“The ShoulderFlex Massager poses serious risks. Consumers should stop using this device, health care providers should not recommend it to their patients, and businesses should stop distributing and selling the device,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.
King International recalled the ShoulderFlex Massager on Aug. 31, 2011. However, during a recent compliance audit, the FDA found that the company has gone out of business and it has not followed through with recall procedures. Many of the companies that sell this device were not made aware of the recall, and King International did not properly notify customers who purchased the massager.
Because of this failure, the FDA is concerned that consumers may not be aware of the risks posed by the ShoulderFlex Massager and may still be using this dangerous product. The FDA recommends that customers and consignees safely dispose of the ShoulderFlex Massagers so that the device cannot be used. The massage fingers and power supply should be removed and disposed of separately from the device. See the FDA announcement.