Class II U.S. Food and Drug Administration

Myofunctional Research Company USA Myosa for Kids KS1 REF MyOsaks1_Sb/Sp/Mb/Mp/Lb/Lc recall: Due to firm mistakenly distributing product within the U.S. without FDA

Recall published 10 months ago

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0956-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Myofunctional Research Company USA
Product type
Medical devices
Units affected
436 devices
Distribution
Nationwide
Made in
United States
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

Products covered by this recall

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:

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • MyOSAKS1
  • MyOSAKS2

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Myofunctional Research Company USA — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Myofunctional Research Company USA — 9627 Charles Smith Avenue, Rancho Cucamonga, CA, 91730

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Myofunctional Research Company USA medical devices recalled?

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number MyOSAKS1, MyOSAKS2. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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