Myosa for Kids mouthguards recalled for lacking FDA clearance
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.
From the FDA notice · Read the official notice ↗
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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:
- Sold in
- Nationwide
- Made for
- Children (3 years to 15 years)
Details
- Units affected
- 436 devices
- Illnesses reported
- None reported
- Manufactured in
- 9627 Charles Smith Avenue, Rancho Cucamonga, CA, United States
- Classification
- Class II
- Recall number
- Z-0956-2026
In the FDA's words
- Description
- 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: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc -S1 Large Blue -S1 Large Clear -S1 Medium Blue -S1 Medium Pink -S1 Small Blue -S1 Small Pink KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc -Stage 2 Large Blue -Stage 2 Large Clear -Stage 2 Medium Blue -Stage 2 Medium Clear -Stage 2 Medium Pink -Stage 2 Small Blue -Stage 2 Small Clear Distribution: 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 quantity: 436 devices
- Hazard
- Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.