(RxWiki News) One gift you might want to make sure is not on your list this season is the ShoulderFlex Massager. Though it might appear to be a relaxation-inducing gift, the FDA is warning to skip the dangerous device.
FDA officials are warning that consumers should not use the device made by King International because it could pose serious health risks, including the risk of dying.
"Stop using the ShoulderFlex Massager immediately."
The personal massage device provides a deep tissue massage to the neck, shoulders and back while lying down. It has been sold by various retailers, by catalog and online, including Amazon.com, Relax the Back and Lifestyle Fascination, by mail order. About 12,000 ShoulderFlex Massagers have been sold since 2003.
Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, emphasized that the device is dangerous and that consumers should not use it.
He said health providers should not recommend it to their patients, and that retailers should stop selling it effective immediately.
Clothing, hair and jewelry can become entangled in the ShoulderFlex Massager causing serious injury or death. There have been reports of one death and one near-death from strangulation.
The company had initially voluntarily recalled the massager on Aug. 31, but the FDA learned during a recent compliance audit that the company had gone out of business and had not followed through with recall procedures.
King International's phone number established for the recall is no longer in service and many retailers were unaware of the recall or did not properly notify consumers who had purchased the product about the recall. FDA officials are concerned that consumers may not be aware of the recall and could still be using the product, or even giving it as a holiday gift.
FDA officials ask that product owners throw the device away by removing the massage fingers and disposing of them separately from the device so that there is no chance the ShoulderFlex device can be reused. They also suggest that the power supply be thrown out separately.
For questions contact the Division of Small Manufacturers, International and Consumer Assistance at 800-638-2041. Consumers also are asked to report adverse events associated with using the device through MedWatch at 800-FDA-1088.
