Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance… — Class II medical device recall Z-2769-2026
Ongoing recall by Prismatik Dentalcraft, Inc., reported 2026-07-29, distributed nationwide. Due to device not having FDA Clearance
| Recall number | Z-2769-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prismatik Dentalcraft, Inc., Irvine, CA, United States |
| Recall initiated | 2026-04-27 |
| Classified | 2026-07-21 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 20 |
| Serial numbers | 1020214577, 1020784354, 1030007997, 1030439672, 1030523763, 1030722759, 1106770735, 1107310424, 1107642834, 1108530251, 1110784932, 1117400787, 1118814629, 1121913952, 1122251905, 1122958036, 1124408531, 1125495087, 1127571733, 1131149684 |
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).
Reason for recall
Due to device not having FDA Clearance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2769-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.