The Food and Drug Administration is urging consumers to avoid using the ShoulderFlex Massager, a shoulder and neck massage device, after reports of one death and one near-strangulation.
In a notice Friday, the agency asked health care providers to tell their patients not to use the device and to throw it out.
The FDA said the fatal and near-fatal incidents happened after a necklace and a bit of clothing got caught in the device, which rotates with use. The agency said it knows of two other episodes where clothing and hair were trapped in the device.
The ShoulderFlex Massager, sold direct-to-consumers, is distributed by King International of Beaverton, Ore. Almost 12,000 massagers have been distributed since Oct. 18, 2003, the FDA said. It runs for about $140 on Amazon.
If you have the product and are going to throw it out, the FDA recommends you take it apart and dispose of the pieces separately, so no one can reassemble it and use it again.
The FDA said it's currently evaluating the distributor's recall plans.