Recall Z-0172-2012 ยท ISA Massager, Therapeutic, Electric
King International
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 w
| Date | Nov 10, 2011 (initiated Aug 30, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| 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 |
| Quantity | 11934 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.