FDA-Device2026-07-29Class IIMISBRANDING
Silent Nite Sleep Appliance recalled — device lacks FDA clearance
What this means
Prismatik Dentalcraft distributed Silent Nite Sleep Appliances (a mandibular advancement device for snoring and sleep apnea) without obtaining required FDA clearance. The devices were sold in multiple states before the clearance status was identified.
- If you own a Silent Nite Sleep Appliance with lot number 1020214577 through 1131149684, contact your dental provider or Prismatik Dentalcraft for instructions.
- Do not discard the device without guidance; your dentist will advise on next steps.
- No injuries have been reported so far.
The agency's original wording
Hazard
Due to device not having FDA Clearance
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Affected count
20
Manufactured in
2144 Michelson Dr, N/A, Irvine, CA, United States
Products
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2769-2026Want us to check the next one for you?
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