Company went out of business without recalling dangerous product
December 25, 2011 (Washington D.C.)--The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.
Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation. There have been reports of one death and one near death, due to strangulation, associated with the use of this device.
The ShoulderFlex Massager is a personal massage device sold in retail stores, catalogs and over the Internet. It is intended to provide users with a deep tissue massage to the neck, shoulders and back area while lying down.
“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 Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.
King International recalled the ShoulderFlex Massager on Aug. 31, 2011; however, during a recent compliance audit, the FDA found that the company has gone out of business. King International has not followed through with recall procedures; 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.
Because of this failure, the FDA is concerned that consumers may not be aware of the risks posed by the ShoulderFlex Massager and may still be using this dangerous product.
The FDA recommends that customers and consignees safely dispose of the ShoulderFlex Massagers so that the device cannot be used. The massage fingers should be removed and disposed of separately from the device; the power supply should be disposed of separately, as well.
If you suspect a problem with the ShoulderFlex Massager, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about the ShoulderFlex Massager safety communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV or 800-638-2041.
For more information:
- FDA Safety Communication: Life Threatening Injuries Associated with the ShoulderFlex Massager
- Recall: King International LLC., ShoulderFlex Deep-kneading Shiatsu Massager
- MedWatch, the FDA Safety Information and Adverse Event Reporting program
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.