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

SILVER SPRING, Md., Dec. 21, 2011 /PRNewswire-USNewswire/ -- 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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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.

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 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
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, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... Mich. , April 28, 2016   ... . Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation,s ... has signed a definitive agreement to acquire Valley ... Specialty Pharmacy ("TNH"), a leading specialty pharmacy that ... Van Nuys, California . In 2015, TNH ...
(Date:4/28/2016)... 28, 2016 Research and Markets ... Surgery Products Market 2016-2020" report to their offering. ... The global plastic surgery products market is ... the period 2016-2020. , ,The growing adoption of laser ... growth of the market. Lasers are used to treat ...
(Date:4/28/2016)... 28, 2016 ... Phillips und Stephen Schmidt ... ArisGlobal®, ein führender Anbieter cloudbasierter Softwarelösungen ... bekannt, dass neue Führungskräfte zum Team Sicherheit ... die vielfältige Erfahrungen mitbringen.  Dies wird die ...
Breaking Medicine Technology:
(Date:5/2/2016)... (PRWEB) , ... May 02, 2016 , ... In honor ... will offer an incentive to people who share their fitness journey on social media. ... premium first aid products, will award a $100 product voucher each week during May ...
(Date:5/2/2016)... ... , ... East Los Angeles dentist , Dr. Ramin Assili, is now ... receive any dental extraction treatment for $40 off the regular price. This promotion cannot ... lower price, patients can more easily afford extractions to eliminate teeth that are damaged ...
(Date:5/2/2016)... ... 02, 2016 , ... Dr. Rassouli, dentist in Orange County, CA ... the research, which was published in the “Journal of the American Geriatrics Society,” more ... million Americans have Alzheimer’s disease. The study found that dental problems may increase the ...
(Date:5/2/2016)... ... ... Pregnancy Awareness Month offers a great time to get familiar with the latest ... to have a baby, it’s best to get started before age becomes an issue,” ... & Pregnancy Organizer, written for women who plan on becoming pregnant to learn about ...
(Date:5/2/2016)... ... ... Dr. Jonathan Kulbersh of Carolina Facial Plastics isn’t surprised that Charlotte, NC, the city where ... 5 US Cities with the Highest Plastic Rates .” The other cities that made ... calculated using a survey by RealSelf and combining that data with the number ...
Breaking Medicine News(10 mins):