FDA recall, , Moderate risk
Silent Nite Sleep Appliance
The Silent Nite Sleep Appliance lacks FDA clearance.
Summary by Recall Canary from the FDA notice
What happened
Prismatik Dentalcraft, Inc., of Irvine, California, began a recall of the Silent Nite Sleep Appliance on April 27, 2026, because the device does not have FDA clearance. The appliance is a mandibular advancement device intended to treat snoring and mild to moderate obstructive sleep apnea.
The FDA added the recall to its Enforcement Report and classified it on July 21, 2026, with the recall in the weekly report on July 29, 2026. Distribution was in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Silent Nite Sleep Appliance
- Model number
- SILNT
- UDI-DI
- 1020214577
- 1020784354
- 1030007997
- 1030439672
- 1030523763
- 1030722759
- 1106770735
- 1107310424
- 1107642834
- 1108530251
- 1110784932
- 1117400787
- 1118814629
- 1121913952
- 1122251905
- 1122958036
- 1124408531
- 1125495087
- 1127571733
- 1131149684
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Arizona, California, Florida, Georgia, Illinois, Indiana, Maryland, Missouri, New York, Texas, and Virginia.
- Company
- Prismatik Dentalcraft, Inc.Irvine, California
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98834
- Recall number
- Z-2769-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
