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U.S. Department of Health and Human Services

Medical Devices

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King International LLC., ShoulderFlex Deep-kneading Shiatsu Massager

Recall Class: Class I

Date Recall Initiated: August 30, 2011

Product: ShoulderFlex Deep-kneading Shiatsu Massager, Model # SH61

This product was manufactured from June 1, 2003 through January 27, 2011 and distributed from October 18, 2003 through April 19, 2011.

See related Safety Communication and Firm Press Release under Additional Links below.

Use: The ShoulderFlex massager is a personal use 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.

Recalling Firm:

King International LLC
16286 SW Horseshoe Way
Beaverton, OR 97007

Reason for Recall: The FDA became aware of one death and one near strangulation associated with the use of the ShoulderFlex massager. Additionally, the FDA was informed of two other reported incidents involving clothing and hair becoming caught in the device.

Public Contact: Customers may contact King International LLC at 1-503-524-7046, through its website (www.shoulderflex.com), or by writing to King International at P.O. Box 2384, Beaverton, OR 97075.  NOTE: As of Dec. 21, 2011, the FDA discovered that the firm has gone out of business and the website and 1-800 phone number established by the firm to handle this recall are no longer available.

FDA District: Seattle

FDA Comments: King International LLC sent customers a letter notifying them about the product recall. In addition to the consumer information below, the letter informed customers to complete and return the enclosed postage-paid card to King International to confirm receipt of the recall letter.

Consumers:

Do NOT use the ShoulderFlex massager. Users of the device should dispose of the device components separately so that the massager cannot be reassembled and used by throwing away the power supply separately and removing the massage “fingers” to dispose of them separately.

Health Care Providers:

Advise your patients NOT to use the ShoulderFlex massager.

Summary of Recall: On August 25, 2011 the FDA published a Safety Communication on the FDA website and updated it on September 6, 2011. On August 31, 2011, the company issued a press release notifying the public about the recall of its Shoulder Flex massager.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links: