Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog... recall (Prismatik Dentalcraft, Inc.)
Medical deviceClass IIOngoing
Summary: Prismatik Dentalcraft, Inc. is recalling 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).. Reason: Due to device not having FDA Clearance.
What is being recalled
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).
Why
Due to device not having FDA Clearance
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA. (states named: Arizona, California, Florida, Georgia, Illinois, Indiana, Maryland, Missouri, New York, Texas, Virginia)
How to tell if yours is affected
Item Number: NITESL UDI-DI code: D745SILNT0 Lot/Serial Numbers: 1020214577 1020784354 1030007997 1030439672 1030523763 1030722759 1106770735 1107310424 1107642834 1108530251 1110784932 1117400787 1118814629 1121913952 1122251905 1122958036 1124408531 1125495087 1127571733 1131149684
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2769-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 27, 2026 |
| Reported | July 29, 2026 |
| Company | Prismatik Dentalcraft, Inc. |
| Company location | Irvine, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20 |
More recalls from Prismatik Dentalcraft, Inc. · all medical device recalls · recalls from April 2026