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MEDICAL DEVICE RECALLMODERATE
Silent Nite Sleep Appliance
The Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.
What to do
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?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Silent Nite Sleep Appliance
- UDI-DI
- 1020214577, 1020784354, 1030007997, 1030439672, 1030523763, 1030722759, 1106770735, 1107310424, 1107642834, 1108530251, 1110784932, 1117400787, 1118814629, 1121913952, 1122251905, 1122958036, 1124408531, 1125495087, 1127571733, 1131149684
- Model/Catalog number
- SILNT
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Unapproved Product recalls
Editorial summary by Recall Canary · summary updated 2026-07-22 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification