Myofunctional Research recalls Myosa for Kids mouthguards sold without FDA premarket approval. These children's mouthguards may pose safety risks if used without proper regulatory clearance.
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Myofunctional Research is recalling Myosa for Kids mouthguards because they were distributed in the U.S. without FDA premarket approval. This means the product may not meet safety standards for children under 15.
The mouthguards were distributed without FDA premarket approval, meaning they may not meet safety standards. This could lead to health risks if used without proper regulatory oversight.
Children aged 3-15 who own or use Myosa for Kids mouthguards are affected. Parents and caregivers are most at risk due to potential safety issues.
Check for product labels with catalog numbers: MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc for KS1 or MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc for KS2. These mouthguards are for children ages 3-15.
Look for catalog numbers: MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc for KS1 or MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc for KS2.
The product was distributed in the U.S. without FDA premarket approval, which may mean it doesn't meet safety standards.
Children ages 3-15 who use Myosa for Kids mouthguards are affected.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Myofunctional Research to request your refund or repair — edit it as you like.
Subject: Recall Z-0956-2026 — Myofunctional Research Myofunctional Research Hello, I own a Myofunctional Research that is covered by recall Z-0956-2026 from Myofunctional Research. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
