BEUDAMED
    FDA Recall Open, Classified

    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:

    Recall: Z-0956-2026 · Initiated October 9, 2025

    Recall

    Recall Number
    Z-0956-2026
    Event Number
    97890
    Firm
    Myofunctional Research Company USA
    FEI Number
    3005505603
    Product Code
    LRK
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    October 9, 2025
    Posted
    December 18, 2025
    Address
    9627 Charles Smith Avenue, Rancho Cucamonga, CA, 91730

    Description

    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.

    Action

    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]

    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

    Quantity

    436 devices