We’re not trying to smear the product. The bad news comes directly from the FDA. The Food and Drug Administration passed judgment on the massager (consumer concerns actually do fall under its jurisdiction) and declared it a hazard to public health. Why? Read on.
Apparently, the root of the problem is several disturbing reports of near strangulation. Worse, there is a single confirmed fatality due to the ShoulderFlex. The cause of death is unreported, but it was enough to raise a stink in the FDA offices. The accidents and lone death are believed to have resulted from a moving gear inside the machine where necklaces and other loose peripherals tend to get stuck.
Details of the Incidents
Among the complaints that the FDA received included claims that hair and clothing also got ensnared while the machine was on. This is particularly concerning because it suggests that the design of the ShoulderFlex did not adequately account for the safety of its users. The moving parts inside the massager, which are supposed to provide relief and relaxation, instead posed a significant risk of injury. The entanglement of hair and clothing could lead to severe injuries, including cuts, bruises, and even more serious harm if the machine is not turned off immediately.
Taking the initiative, the FDA wasted no time issuing its warning to the public. The agency’s swift action underscores the severity of the risk posed by the ShoulderFlex. The FDA’s warning is not just a precautionary measure; it is a direct response to the real and present danger that the product represents.
Impact and Response
To date, some 12,000 ShoulderFlex massagers have been sold. This number is significant because it means that thousands of consumers are potentially at risk. The FDA now warns that owners should dispose of their machines. This recommendation is not made lightly; it reflects the agency’s assessment that the risk of using the ShoulderFlex outweighs any potential benefits.
The manufacturer is also being sanctioned, which means they are likely facing fines and other penalties. This action is intended to hold the company accountable for releasing a product that endangers public health. The sanctions may also serve as a deterrent to other manufacturers, signaling that the FDA will take strong action against companies that fail to ensure the safety of their products.
The ShoulderFlex has now been removed from Amazon, one of the largest online marketplaces. This removal is a critical step in preventing further sales and reducing the risk to consumers. Amazon’s decision to pull the product likely came after discussions with the FDA and a review of the evidence presented. It also highlights the role that retailers play in ensuring product safety; by removing hazardous items from their platforms, they help protect their customers.
In addition to the FDA’s actions, consumer advocacy groups are likely to get involved. These organizations can provide additional support and resources to affected consumers, helping them understand their rights and options. They may also push for broader regulatory changes to prevent similar issues in the future.
The case of the ShoulderFlex serves as a stark reminder of the importance of product safety. Consumers should always be vigilant and report any issues with products to the appropriate authorities. Manufacturers, on the other hand, must prioritize safety in their design and testing processes to avoid endangering their customers.
Source Thirdage
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