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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a premarket clearance shortfall with no stated product defect, consequence or reported harm.
Plain-English summary
Myosa for Kids, references MyOSAKS1 and MyOSAKS2 in small, medium and large sizes, is being recalled. The record describes the product as a mouthguard for children aged 3 to 15 used to address breathing and myofunctional disorders.
The reason given in the enforcement record is that the firm mistakenly distributed the product within the United States without FDA premarket clearance or approval.
The record lists 436 devices, with size and colour variants listed in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes a regulatory clearance issue rather than a specific product defect, and states no injuries. Customers should follow the firm's instructions.
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:
- Manufacturer
- Myofunctional Research Company USA
- Category
- Medical Device — Oral appliance
- Hazard
- unapproved-device
- premarket-clearance
- regulatory
Distribution
Distributed nationwide across the United States.
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