FDA - Food & Drug Administration

King International's Shoulderflex Massager Recalled by FDA

Device manufacturer, King International LLC, has recalled approximately 12,000 neck massagers sold since 2003 due to a risk of strangulation and death.

In cooperation with the FDA, King International LLC has initiated a recall of the Shoulderflex Deep Kneading Shiatsu massager due to a potential risk for strangulation and death. According to investigators, a South Florida woman was using a Shoulderflex neck massager while wearing a necklace and was strangled to death by the device last Christmas Eve. Reports indicate that the necklace become entangled with an exposed rotating gear on the electric massaging device, causing her carotid artery to be fatally compressed. This massager recall affects all of the approximately 12,000 Shoulderflex massagers which were sold between 2003 and 2011. The massagers were sold at a number of stores, including Relax the Back, in catalogs, including Lifestyle Fascination, and online retailers like Amazon in the United States.

FDA Recommendations for Consumers

The Shoulderflex Deep Kneading Shiatsu massager requires consumers to lay down while using the device, placing the neck between "massage fingers" in order to relieve stress and muscle tension. Although the Shoulderflex massager is still being sold online for $129, King International has informed the FDA that it is beginning to recall the device. Consumers, retailers and catalog sellers are being advised to immediately discontinue the use of Shoulderflex massagers, and to safely dispose of them in the trash. King International has even recommended that the components of the device be disposed of separately to prevent the massager from being reassembled and used. The most effective way is to dispose of the massager unit separate from the power supply, and to remove the massage fingers and dispose of them separately as well.

Massager Poses Risk of Strangulation and Death

This Shoulderflex massager recall was initiated by King International as part of its commitment to safety, due to a report of strangulation and death. There was a warning on the device to avoid entanglement by never wearing a necklace when using the massager. According to an FDA representative, "There was another incident with a near strangulation from another consumer, and we recently learned that King International, who is the distributor of the medical device, has two additional reports of incidents involving clothing and hair becoming caught in the device." King International shares the FDA's desire to take prompt action to reduce the risk of consumer injury. As a result, King International has asked consumers, retailers and catalog sellers to immediately stop using Shoulderflex massagers and to safely dispose of them in the trash.

*** News - FDA - Food and Drug Administration