Myosa for Kids (Myofunctional) – Unauthorized Distribution (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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:
Brand
Myofunctional Research Company USA
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Myofunctional Research Company USA is recalling Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for due to Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Recommended Action
Per FDA guidance
On 10/09/2025, the firm emailed an "URGENT: Medical Device Recall" letter to customers informing them that products (Myosa for Kids KS1 and Myosa for Kids KS2) were distributed in the United States without the required FDA premarket clearance. Customers are instructed to: 1. Immediately examine their inventory for the affected products. 2. Cease distribution/use of any remaining Myosa KS1 and KS2 devices. 3. Quarantine affected stock to prevent further use. 4. Complete and return the enclosed Response Form within 10 business days, even if customers no longer have any affected product. 5. Return quarantine devices using the instructions provided after receipt of customer response forms For any patient who has initiated treatment with the affected devices or to whom you have not explained the risks associated with these devices, it is requested that you notify them and provide warning s and clinical alternatives as appropriate. For questions and/or assistance - Contact Recall Coordinator at 909-587-4940 or email usa.hq@myoresearch.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026