Myofunctional Research Company USA recalls Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/L…

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 usa.hq@myoresearch.com

• FDA enforcement recordOfficial FDA database entry for Z-0956-2026
• FDA device classification · LRKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.5570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Myofunctional Research Company USASearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.