Mouthguard Recall: Myosa for Kids KS1 KS2
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 |
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.
How to identify the recalled item
| Lot / date codes | 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 |
|---|---|
| Lot / date codes | 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 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.