FDA Deems ShoulderFlex Massager Recall Class I

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. At that time, the U.S. Food & Drug Administration (FDA) announced that the ShoulderFlex Massager was associated with at least one death and one near-strangulation.

Now, the FDA has 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.

The recalled ShoulderFlex Deep-Kneading Shiatsu Massager involved are Model # SH61 and were manufactured from June 1, 2003 through January 27, 2011 and distributed from October 18, 2003 through April 19, 2011. The recalling firm is King International LLC, which is located at 16286 SW Horseshoe Way, Beaverton, Oregon, 97007. King International can be reached at 1.503.524.7046; through its website at www.shoulderflex.com; or in writing at P.O. Box 2384, Beaverton, Oregon, 97075.

The recalled ShoulderFlex massager is a personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder, and back while the user lies on a flat surface. As we’ve mentioned, the device consists of a massage unit that sits beneath the neck, a handheld controller, a memory foam pillow and a machine-washable sleeve. The device contains a rotating bar with removable massage “fingers” that may be adjusted by the user to customize the massage area and depth.

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.

King International LLC sent customers a letter notifying them about the product recall and to complete and return an enclosed postage-paid card to King International to confirm receipt of the recall letter.

According to the FDA, the ShoulderFlex Massager SHOULD NOT BE USED. The agency has also recommended that doctors advise their patients not to use this device.

Consumers have also been asked to dispose of the ShoulderFlex Massager in such a way that device can’t be reassembled and used. As such, the power supply should be disposed of separately. The massage fingers should be removed, and also disposed of separately.

King International distributed 11,934 ShoulderFlex Massagers since October 18, 2003, according to the FDA previously. The devices were sold at various stores and online retailers in the United States.

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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