# FDA recall Z-0956-2026

> **Myofunctional Research Company USA** · Class II · device recall initiated 2025-10-09.

## 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

- **Recall number:** Z-0956-2026
- **Recalling firm:** Myofunctional Research Company USA
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0956-2026. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0956-2026. Source: US FDA. Licensed CC0.

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