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:
This recall is currently active, issued December 18, 2025. It was issued by Myofunctional Research Company Usa.
- Recall Initiated
- October 9, 2025
- Posted
- December 18, 2025
- Recall Number
- Z-0956-2026
- Quantity
- 436 devices
- Firm Location
- Rancho Cucamonga, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
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
Lot / Code Info
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
Root Cause
No Marketing Application
Action Taken
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