FDA Issues Another Warning For ShoulderFlex Massager

The U.S. Food & Drug Administration (FDA) just issued another warning for the ShoulderFlex Massager and is warning consumers, again, not to use the device, which is imported by King International and sold by various companies.

The ShoulderFlex Massager has been linked to serious potential health risks. For instance, hair, clothing, or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury, even death, from strangulation.

To date, there has been a report of one death and a report of one near-death, due to strangulation, associated with the use of the ShoulderFlex Massager.

The ShoulderFlex Massager is a personal massage device sold in retail stores, catalogs, and over the Internet and is intended to provide users with a deep tissue massage to the neck, shoulders, and back area while lying down.

King International recalled the ShoulderFlex Massager on August 31, 2011; however, during a recent compliance audit, the FDA discovered that King International has gone out of business, King International has not followed through with recall procedures, the 800 number established by King International for this recall is no longer in service, and many of the companies that sell this device are not aware of the recall or did not properly notify customers who purchased the defective ShoulderFlex Massager.

“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.

The FDA also recommends that customers and consignees safely dispose of the ShoulderFlex Massagers so that the device cannot be used. The massage fingers should be removed and disposed of separately from the device; the power supply should be disposed of separately, as well.

This August, we wrote that U.S. health regulators warned consumers not to use the ShoulderFlex Deep-Kneading Shiatsu Massager over a potential strangulation risk. Following that, we wrote that the FDA deemed the recall that was initiated on August 30, 2011 as a Class I recall, its most serious. Class 1 recalls involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

In addition to the one death and one near strangulation associated with the use of the ShoulderFlex massager, the FDA said it was advised of two other reported incidents involving clothing and hair becoming caught in the device. Both the fatality and near-strangulation associated with the ShoulderFlex Massager occurred when a necklace and clothing became caught in a piece of the device that rotates during use.

Consumers who suspect a problem with the defective ShoulderFlex Massager are encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program, at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

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