Recall Z-0956-2026 ยท LRK Device, Anti-Snoring
Myofunctional Research Company USA
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:
| Date | Dec 18, 2025 (initiated Oct 9, 2025) |
| Status | Open, Classified |
| Reason | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. |
| Root cause | No Marketing Application |
| 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. Retu |
| Quantity | 436 devices |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.