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 mouth
Summary
The FDA issued a Class II for Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/ by Myofunctional Research Company USA. Reason: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval..
Details
Source
Device Recall
External ID
Z-0956-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
Product Description
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:
Lot/Code Info: 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
Quantity Affected: 436 devices
Reason for Recall
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-09
Company
Rancho Cucamonga, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Myofunctional Research Company USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Myofunctional Research Company USA have FDA actions?
This is the only FDA action we have on record for Myofunctional Research Company USA in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0956-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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