Myofunctional Research Company USA: Device Recall
Recall #Z-0956-2026 · 10/09/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0956-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Myofunctional Research Company USA
- Status
- Ongoing
- Date Initiated
- 10/09/2025
- Location
- Rancho Cucamonga, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 436 devices
Reason for Recall
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
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:
Distribution Pattern
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.