CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report
Myosa for Kids KS1 recalled by Myofunctional Research
Myofunctional Research Company USA is recalling Myosa for Kids KS1, distributed nationwide in the US. The recall was initiated on 9 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0956-2026
- FDA event ID
- 97890
- Recalling firm
- Myofunctional Research Company USA, Rancho Cucamonga, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2025
- FDA classified
- 18 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Oct 2025 | Recall initiated by company | |
| 18 Dec 2025 | Classified by FDA | +70 days |
| 24 Dec 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Product as listed by the FDA
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:
Where it was distributed
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
Nationwide AlaskaArkansasCaliforniaColoradoFloridaGeorgiaHawaiiIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaNorth CarolinaNew JerseyNew MexicoNew YorkOhio
Questions about this recall
Why was it recalled?
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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