August 25, 2011, FDA
The ShoulderFlex Massager, distributed by King International in Beaverton, OR, is a personal 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. It 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.
The purpose of this Safety Communication is to urge consumers and health care professionals to stop using the ShoulderFlex Massager because of the risk of strangulation or other serious injury.
Summary of Problem and Scope:
The FDA is aware of reports to the Consumer Product Safety Commission of one death and one near-strangulation associated with the ShoulderFlex Massager. These incidents occurred when a necklace and clothing became caught in a piece of the device that rotates during use. The FDA is aware of two other reports of incidents involving clothing and hair becoming caught in the device.
The FDA is concerned that the ShoulderFlex Massager presents serious health risks. Hair, clothing, and jewelry can become entangled in the massage device and cause serious injury or death.
King International has distributed 11,934 devices since Oct. 18, 2003. The devices were sold at various stores and online retailers in the United States.
Recommendations for Consumers:
Do NOT use the ShoulderFlex massager.
Dispose of the device components separately so that the massager cannot be reassembled and used:
Dispose of the power supply separately.
Remove the massage fingers and dispose of them separately.
Recommendations for Health Care Providers:
Advise your patients NOT to use the ShoulderFlex massager.
The FDA is evaluating King International’s plan for recall of the ShoulderFlex Massager, which may lead to additional action or communication by the FDA or King International.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the ShoulderFlex Massager, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at VOG.SHH.ADF|ACIMSD#VOG.SHH.ADF|ACIMSD, 800-638-2041 or 301-796-7100.