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:

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

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 [email protected]