ShoulderFlex Recall Elevated to Class I Status

A death, a near strangulation and other serious problems associated with the ShoulderFlex massager, have led federal regulators to classify an August recall in their most serious category for defective medical devices. 

On Wednesday, the FDA announced that the recent ShoulderFlex massager recall had earned a Class 1 medical device recall designation due to the serious risks associated with using the massager.

The classification is reserved for the most serious types of recalls, where there is a reasonable probability that the use of the device will cause serious injury or death.

King International, LLC pulled about 12,000 ShoulderFlex massagers from the market on August 31, following an FDA safety communication warning to consumers on August 25, which indicated that there were reports of serious problems with the massagers.

Those problems led to at least one death, and another person was nearly strangled by the massager. In addition, there have been reports of clothing and hair becoming caught in the device.

The ShoulderFlex Massager is a deep tissue personal massage device designed to massage the shoulder, neck and back. 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 FDA warned that necklaces, hair and clothing can get caught in a rotating part of the massager, leading to a strangulation risk. The agency is calling on doctors to warn their patients not to use the devices and ask both doctors and patients to report any incidents to MedWatch, the FDA’s adverse event reporting program. 

King International does not appear to be offering refunds to consumers who purchased the defective massagers, and instead of asking that they be returned, the company is calling on consumers to disassemble the devices themselves and throw the parts away separately so they cannot be reassembled. The company said the most effective means of doing so is to throw away the power supply separate from the massager and to remove all of the massage fingers and throw those away separately as well.

Consumers with questions can contact King International LLC at (503) 524-7046 or at its website at www.shoulderflex.com. They can also write to the company at King International, P.O. Box 2384, Beaverton, OR 97075.