FDAFDA · Food and drugs·Recall number Z-2769-2026
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).
Published July 29, 2026 · Recall initiated: April 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to device not having FDA Clearance
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Prismatik Dentalcraft, Inc.
- Distributor
- U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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