UnratedMedical device recall · FDA · Published April 27, 2026
Silent Nite Sleep Appliance Recall: FDA Clearance Missing
Prismatik Dentalcraft recalls Silent Nite Sleep Appliance (model SILNT) due to lack of FDA clearance. Consumers should contact the company for details on next steps.
Prismatik Dentalcraft is recalling Silent Nite Sleep Appliance models with catalog number SILNT because the device lacks FDA clearance. This means the product has not been approved for safety and effectiveness by the U.S. Food and Drug Administration. Read more at govinfonow.com/recall/128179-silent-nite-sleep-appliance-recall-fda-clearance-missing.
“Silent Nite Sleep Appliance Recall: FDA Clearance Missing.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/128179-silent-nite-sleep-appliance-recall-fda-clearance-missing. Based on FDA recall #Z-2769-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2769-2026%22&limit=1).
The FDA announced on April 27, 2026, that Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances due to a lack of FDA clearance. The agency classified the recall as Class II.
Distribution: U.S. Nationwide in AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA
The hazard
The recall is due to the devices not having FDA clearance. GovInfoNow's records show 1,244 reports in the FDA's MAUDE database naming Silent Nite since April 2025, with 39 marked as serious.
Context
GovInfoNow's records show Prismatik Dentalcraft, Inc. has two other recalls on record since April 14, 2025. On September 30, 2025, the company issued a recall for Inclusive Titanium Screws due to incorrect titanium screws being packaged with dental implants. Other recent recalls of similar products include Medline ENT Kits Recall (February 25, 2026), Medline Syringes Recall (February 25, 2026), and Edermy PIE PAK Models P2HC-A, P2HC-S, P2HC Recall (January 14, 2026).
How to tell if you have this one
Check for the catalog number SILNT on the product. The affected models include specific lot/serial numbers listed in the recall notice.
Brand
Silent Nite
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Prismatik Dentalcraft for information on the recall and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Indiana, Maryland, Missouri, New York, Texas, Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2769-2026 (April 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2769-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.