Children's mouthguards recalled for distribution without FDA premarket clearance
Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.
- 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:
- Category
- Medical Device
- Distribution
- Distributed nationwide