FDA Device Recall - Consumer Justice Foundation

FDA Device Recall

Written by Faith Anderson on September 1, 2011
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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.

Posted Under: FDA - Food and Drug Administration
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