The ShoulderFlex Massager has killed one user and caused one near strangulation, according to the U.S. Food and Drug Administration (FDA).
The dangerous incidents occurred when a necklace and clothing became caught in a piece of the device that rotates during use.
Two other incidents involving hair and clothing were also reported, according to the FDA.
The FDA is recommending that users dispose the device (and separately by components, too, so it won't be reassembled and used).
Following FDA's footsteps, the Hong Kong Department of Health urged residents to stop using the product because of its association with strangulation and severe injuries.
The ShoulderFlex Massager is distributed by U.S. company King International. The massager, pictured upper left, provides deep tissue massage while the user lies on his back in a flat surface.
Since October 18, 2003, King International has distributed 11,934 ShoulderFlex Massagers. The FDA is currently monitoring the company's plan for recall in light of the strangulation reports.