Silent Nite Sleep Appliance Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Prismatik Dentalcraft, Inc. is recalling 20 Silent Nite Sleep Appliances distributed nationwide due to the device lacking FDA clearance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Prismatik Dentalcraft, Inc. initiated a voluntary recall of the Silent Nite Sleep Appliance because the device does not have FDA clearance.
Which Products Are Affected
The recall involves the Silent Nite Sleep Appliance (Brand Name: Silent Nite; Model/Catalog Number: SILNT; Item Number: NITESL; UDI-DI code: D745SILNT0). A total of 20 units are affected, with the following lot/serial numbers: 1020214577, 1020784354, 1030007997, 1030439672, 1030523763, 1030722759, 1106770735, 1107310424, 1107642834, 1108530251, 1110784932, 1117400787, 1118814629, 1121913952, 1122251905, 1122958036, 1124408531, 1125495087, 1127571733, 1131149684. The products were distributed to U.S. Nationwide in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA. The recall number is Z-2769-2026.
What You Should Do
Consumers should refer to the recalling firm for further information on the affected devices.
Why This Matters
The recall affects a mandibular advancement device intended to treat snoring and mild to moderate obstructive sleep apnea, with distribution across multiple states.
Source
FDA recall Z-2769-2026 (event ID 98834), Class II, ongoing.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,177 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.