--- title: "Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/M... — FDA record Z-0956-2026 | Is It on Recall" description: "Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval." url: https://isitonrecall.com/recall/fda-device-z-0956-2026-myosa-for-kids-ks1-ref-myosaks1-sb-sp-mb-mp-lb-lc-ks2-ref-myosaks2-sb-sc-mb-mc-mp-lb-lc-myosa-for-ki/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # 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 mouthguar... — FDA record Z-0956-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 9, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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. - **Classification**: Class II - **Recalling firm**: Myofunctional Research Company USA - **Quantity**: 436 devices - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0956-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0956-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## 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 States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Dec 24, 2025 - **Recall initiation date**: Oct 9, 2025 - **Center classification date**: Dec 18, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0956-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Myofunctional Research Company USA records](https://isitonrecall.com/brand/myofunctional-research-company-usa/)