ShoulderFlex Massager Linked to Risk of Strangulation, Death: FDA

Federal regulators are warning that problems with ShoulderFlex Massagers have been linked to reports of strangulations and at least one death. 

The FDA issued a safety communication on August 25, indicating that the design of King International’s ShoulderFlex Massager could cause serious and potentially life-threatening injuries.

According to the agency, necklaces, hair and clothing can get caught in a rotating part of the massager, which could lead to the strangulation of consumers. At least one death, one serious injury and two other reports of clothing and hair getting caught in the device have been reported to the FDA.

The ShoulderFlex Massager is a deep tissue personal massage device designed to massage the shoulder, neck and back. Nearly 12,000 of the devices have been distributed by King International since October 2003. The massager includes the massage unit, a handheld controller, a memory foam pillow and machine-washable sleeve. The massage “fingers” can be removed and adjusted.

The warning issued by the FDA was not a ShoulderFlex recall, but the agency said it was in talks with the company about plans for one in the near future.

In the interim, the FDA is urging consumers not to use the ShoulderFlex massager and to dispose of the components, massage fingers and power supply separately so that the device cannot be reassembled. The agency is also asking doctors to advise their patients not use the ShoulderFlex as well.

The FDA is asking any consumers who experience an adverse event while using a Shoulder Flex to report those problems to MedWatch, the FDA’s adverse event reporting program.