FDA Safety Communication: UPDATE on Life-Threatening Injuries Associated with the ShoulderFlex Massager

Date Issued: December 21, 2011

Audience:

• Consumers who have purchased or use the ShoulderFlex Massager
• Businesses that sell the ShoulderFlex Massager
• Health care professionals who recommend the ShoulderFlex Massager to their patients

Medical Specialties: Physical Therapy, Orthopedics, Physical Medicine

Device:  

The ShoulderFlex Massager, importeded by King International in Beaverton, OR and sold by various companies, 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. 

Purpose:

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.

The FDA is issuing this update to notify the public about King International’s recall of its ShoulderFlex Massager and to provide information about the recall.

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.

FDA Activities: 

• On August 31, 2011, King International issued a press release notifying the public about the recall of its ShoulderFlex Massager.
• On Dec. 21, 2011, the FDA issued a press release notifying the public that during a recent compliance audit, the FDA discovered that the firm had gone out of business. Before closing its doors, King International failed to follow through with appropriate recall procedures and the 1-800 phone number established by the firm to handle this recall is no longer in service. The FDA is concerned that consumers may not be aware of the risks posed by the ShoulderFlex Massager and may still purchase or use this dangerous product. Many of the companies that sell this device may not be aware of the recall or may not have properly notified customers who purchased the massager.

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.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices