FDA Recall Terminated

Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China." Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface.

Recall: Z-0172-2012 · Initiated August 30, 2011

Recall

Recall Number
Z-0172-2012
Event Number
59829
Firm
King International
FEI Number
3004168104
Product Code
ISA
Status
Terminated
Root Cause
Component design/selection
Initiated
August 30, 2011
Posted
November 10, 2011
Terminated
March 6, 2014
Address
16286 Sw Horseshoe Way, Beaverton, OR, 97007

Description

Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China." Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface.

Reason

The covered rotating mechanism can catch on user's clothing, jewelry (e.g. necklace), and hair. There have been reports of one death and a strangulation associated with using the device.

Action

An Urgent Product Recall letter was sent via regular mail to customers. The letter identified the affected product and described the reason for the recall. Customers were asked to stop using Shoulderflex massagers immediately and to safely dispose of them in the trash. The device components should be disposed of separately so that the device cannot be reassembled and used. This means that the power supply should be separated from the massager unit, and the massage fingers should also be removed and disposed of separately. Customers are to complete and return the enclosed the postage-paid card to King International in order to confirm receipt of the recall letter. If additional information is needed regarding this recall, customers are to contact King International LLC at 503-524-7046 or visit their website at www.shoulderflex.com or via mail to PO Box 2384, Beaverton, Oregon 97075. On 8/25/2011 FDA published a health alert on the FDA website. On 8/31/2011 the firm issued a nationwide press release.

Distribution

Nationwide Distribution

Quantity

11934