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FDA: Do Not Use ShoulderFlex Massagers
Date:12/21/2011

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
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm269721.htm

Recall: King International LLC., ShoulderFlex Deep-kneading Shiatsu Massager
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm280135.htm

MedWatch, the FDA Safety Information and Adverse Event Reporting program
http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

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
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SOURCE U.S. Food and Drug Administration
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