medical MODERATE Updated 2026-07-29

Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Ap

See all recalls from Prismatik Dentalcraft, Inc. →

Recalled Product

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).

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Hazard / Issue

Due to device not having FDA Clearance

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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 Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Brand Name: Silent Nite →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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