Recall Z-2769-2026 ยท LRK Device, Anti-Snoring
Prismatik Dentalcraft, Inc.
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).
| Date | Jul 21, 2026 (initiated Apr 27, 2026) |
| Status | Open, Classified |
| Reason | Due to device not having FDA Clearance |
| Root cause | Process control |
| Action | On 04/27/2026, the firm sent via FedEx an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" Letter to customers informing them that Prismatik discovered that a subset of Silent Nite (Product SKU Number: SILNT, Product ID: NITESL) devices were manufactured using Erkoflex-95, a material not cleared by the FDA for manufacturing the Silent Nite. Customers are instructed to: 1. What should Customers do with the product? For the product listed above, please discontinue use and if you have the product with you, please return it to receive a credit, using the return form attached with the specific contact i |
| Quantity | 20 |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA. |
| FDA record | Open on fda.gov |