Death leads to FDA warning about Shoulderflex massager

Posted Dec. 21, 2011, at 10:42 p.m.

PHILADELPHIA  — After reports of a strangulation death associated with using the Shoulderflex massager, the federal Food and Drug Administration warned consumers Wednesday not to use the device.

The massager is sold through retail stores, catalogs and the Internet. It is intended to provide a deep-tissue massage to the neck, shoulders and back area while lying down.

The FDA said hair, clothing or jewelry can become entangled and can cause serious injury or even death.

“The Shoulderflex poses serious health 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.

On Aug. 31, the massager’s manufacturer, King International LLC, said it was voluntarily recalling the device after the report of a strangulation death associated with the massager.

The company urged consumers to stop using the devices and “safely dispose of them in the trash.”

King International said about 12,000 Shoulderflex massagers were sold between 2003 and 2011.

The FDA said Wednesday that during a recent compliance audit, they discovered that King International had gone out of business.

“King International has not followed through with recall procedures … and many of the companies that sell this device are not aware of the recall or did not properly notify customers who purchased the massager,” the FDA said Wednesday.

Both a telephone number and a recall website King International set up Aug. 31 are no longer in service.

 

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