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FDA tells consumers not to use ShoulderFlex Massager

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December 22, 2011|By Deborah Kotz

If you own a ShoulderFlex Massager, get rid of it, said the US Food and Drug Administration in a warning issued today. The device -- which delivers a deep tissue massage to the neck, shoulders, and back while you’re lying down -- was recalled last August after it killed one user and resulted in the near-strangulation of another. But the agency is concerned that the now bankrupt company, King International, didn’t do a good enough job recalling the product before it went out of business.

“King International has not followed through with recall procedures,” read the FDA press release. “The 800 number established by the firm 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 massager.”

Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager as it kneads on muscles, causing serious injury or even death from strangulation, according to the FDA. (Here are more details on the risks.)

“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 FDA compliance director Steve Silverman in a statement.

Owners of the device should dispose of it by removing the massage fingers so it can’t be used. Anyone who has been injured from the device can file a report with the FDA’s MedWatch program.