#shoulderflex

A DH spokesman remarked that the ShoulderFlex massager is designed for home use to provide deep tissue massage to the neck, shoulders and back while the user lies on a flat surface. "Through the department's medical device surveillance scheme, we learnt that there were a few reports of either death or near-strangulation associated with the ShoulderFlex massager in the U.S.

The FDA is WARNING that the SHOULDERFLEX MASSAGER poses risk of serious injury, potential strangulation and/or death. The subject product is illustrated above a 'promotional' video we found on YouTube this morning. Please do not recommend or promote the use of this product per the FDA Bulletin and information below.

However, the FDA has issued a Safety Communication that reports that both the FDA & CPSC are aware of at least one (1) death and one (1) near strangulation associated with the ShoulderFlex Massager. Both were reported as occurring when a necklace or clothing became caught in the device while in operation. Other reports include hair or clothing become caught in the device. 

The ShoulderFlex Massager is distributed by King International as a personal device for deep tissue massage of the neck, shoulders and back. Nearly 12, 000 devices have been sold or distributed since October 18, 2003.

Whether a #recall or retro-fitting of this device is forthcoming remains to be seen. Given the amount of time the product has been on the market, as well as secondary markets via garage sales, Craigslist, Amazon & E-Bay, we will monitor and report on this subject as information becomes available.

Please note that, the FDA is recommending that you do not use or recommend the use of this product. Rather, you dispose of the device components separately to prevent reassembly or use. The FDA is currently evaluating the manufacturer's plan for a recall which may lead to additional bulletins or information.