FDA-Device2025-12-24Class IIMISBRANDING
Myosa for Kids mouthguard recalled for unapproved FDA distribution
What this means
Myofunctional Research Company USA distributed Myosa for Kids mouthguards in the U.S. without FDA approval. The company mistakenly sold approximately 436 units of these devices, which are designed for children ages 3–15 to help with breathing and myofunctional disorders. No injuries have been reported.
- Stop using the Myosa for Kids mouthguard immediately
- Contact Myofunctional Research Company USA for instructions on returning or disposing of the device
- Consult your child's doctor or healthcare provider about approved alternatives
The agency's original wording
Hazard
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Intended for
Children (3 years to 15 years)
Illnesses reported
None reported
Sold states
U.S. (nationwide) distribution to states of: Nationwide: AK, AR, CA, CO, FL, GA, HI, IL, KS, KY, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, and WA; O.U.S. (foreign) to country of: Australia
Affected count
436 devices
Manufactured in
9627 Charles Smith Avenue, Rancho Cucamonga, CA, United States
Products
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0956-2026Want us to check the next one for you?
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