Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF… — Class II medical device recall Z-0956-2026
Ongoing recall by Myofunctional Research Company USA, reported 2025-12-24, distributed nationwide. Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
| Recall number | Z-0956-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Myofunctional Research Company USA, Rancho Cucamonga, CA, United States |
| Recall initiated | 2025-10-09 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 436 devices |
| Model numbers | KS2 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0956-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.