Z-0172-2012

Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex...

Name: Z-0172-2012 Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex...
Creator: King International
Published: 2011-08-30
License: https://open.fda.gov/license/

King International / initiated 2011-08-30 / Terminated / root cause: design

FDA source

King International began a recall of Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all... on 2011-08-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0172-2012
Status: Terminated
Initiated: 2011-08-30
Posted: 2011-11-10
Terminated: 2014-03-06
Recalling firm: King International
Product: 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.
Product code: ISA Massager, Therapeutic, Electric
Reason for recall: 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 tag: design
FDA 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 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.
Quantity in commerce: 11934
Distribution: Nationwide Distribution
Product codes and lots: Model # SH61

Product code ISA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)