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).
USBrand 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).
Recalling Firm: Prismatik Dentalcraft, Inc.
Motivo del Retiro / Peligro
TranslatedDue to device not having FDA Clearance
Descripción del Producto e Identificación
TranslatedBrand 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).
Productos Afectados
TranslatedBrand 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).
Additional Source Details
| Field | Value |
|---|---|
| City | Irvine |
| State | CA |
| Event id | 98834 |
| Address 1 | 2144 Michelson Dr |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 92612-1304 |
| Report date | 20260729 |
| Product type | Devices |
| Product quantity | 20 |
| Reason for recall | Due to device not having FDA Clearance |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | N/A |
| Center classification date | 20260721 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Si...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsablePrismatik Dentalcraft, Inc.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionU.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
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🚨 SAFETY ALERT: 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). Check if your household is affected: https://therecallfile.com/es/recalls/brand-name-silent-nite-product-name-silent-nite-sleep-appliance-model/FDA-Z-2769-2026
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