CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
Silent Nite Sleep Appliance recalled by Prismatik Dentalcraft
Prismatik Dentalcraft is recalling Silent Nite Sleep Appliance, distributed nationwide in the US. The recall was initiated on 27 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2769-2026
- FDA event ID
- 98834
- Recalling firm
- Prismatik Dentalcraft, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Apr 2026
- FDA classified
- 21 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Apr 2026 | Recall initiated by company | |
| 21 Jul 2026 | Classified by FDA | +85 days |
| 29 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to device not having FDA Clearance
Product as listed by the FDA
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).
Where it was distributed
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Nationwide ArizonaCaliforniaFloridaGeorgiaIllinoisIndianaMarylandMissouriNew YorkTexasVirginia
Questions about this recall
Why was it recalled?
Due to device not having FDA Clearance
Which lots are 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
Where was it sold?
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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