Mouthguard Recall: Myosa for Kids KS1 KS2
Announced 2025-12-24 · FDA
Recall involves Myosa for Kids mouthguards in KS1 and KS2 variants intended for children aged 3-15 to address breathing and myofunctional disorders. The devices were distributed in the United States nationwide and to Australia without FDA premarket clearance/approval. About 436 devices were distributed before the recall.
| Brand | Myofunctional Research Company USA |
|---|---|
| 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 | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. |
| Severity | moderate |
| Units affected | 436 |
| 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 |
| Agency | FDA |
| Recall / campaign no. | Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc -S1 Large Blue -S1 Large Clear -S1 Medium Blue -S1 Medium Pink -S1 Small Blue -S1 Small Pink KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc -Stage 2 Large Blue -Stage 2 Large Clear -Stage 2 Medium Blue -Stage 2 Medium Clear -Stage 2 Medium Pink -Stage 2 Small Blue -Stage 2 Small Clear |
WHAT YOU SHOULD DO
- Stop using the affected mouthguards immediately.
- If you own a KS1 or KS2 variant, contact Myofunctional Research Company USA or the retailer for instructions on return, replacement, or refund.
- Keep the product and your purchase information available for the recall process.
- Check the FDA recall page or this notice for updates.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.