Myofunctional Research Company USA has voluntarily recalled 436 Myosa for Kids mouthguards because they were mistakenly distributed in the United States without the required FDA premarket clearance or approval. These devices are intended for children ages 3 to 15 to help address breathing and myofunctional disorders. The recall affects both KS1 and KS2 models in various sizes and colors, including blue, clear, and pink.
Because these devices were distributed without FDA clearance, their safety and effectiveness for treating breathing disorders in children have not been reviewed or verified. This may result in ineffective treatment or unknown health risks for the user.
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Intended for children ages 3-15 to address breathing and myofunctional disorders.
Intended for children ages 3-15 to address breathing and myofunctional disorders.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.