FDA recall Z-0956-2026

Myofunctional Research Company USA · Class II · device

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 for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-10-09
Report date
2025-12-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rancho Cucamonga, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0956-2026