Recall Z-0956-2026— Myofunctional Research Company USA
Class II · Ongoing
Class II FDA medical device recall by Myofunctional Research Company USA, initiated 2025-10-09. FDA's recall record names no specific 510(k) clearance for this event. 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:. Reason: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval..
- Recalling firm
- Myofunctional Research Company USA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-09
- Firm location
- Rancho Cucamonga, CA, United States
Product 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:
Reason for recall
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.