Myofunctional Research Company USA recalls 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 mouth

Recalled December 24, 2025 · FDA recall Z-0956-2026 · Myofunctional Research Company USA

Hazard

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. · FDA Class II

Units

436 devices

Sold at

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

Description

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/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:

Manufacturer(s)

Myofunctional Research Company USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →