Silent Nite Sleep Appliance
The Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.
Stop using the device immediately and contact your dental provider or the manufacturer for further guidance.
Why it was recalled
The Silent Nite Sleep Appliance is being recalled because the device lacks the required FDA clearance for marketing. The affected model is SILNT.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
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 source
Editorial summary by Recall Canary · last updated 2026-07-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification