{"recall":{"id":"fda-device-98834","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Descript","firm":"Prismatik Dentalcraft, Inc.","date":"2026-04-27","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"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).","code":"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","quantity":"20","number":"Z-2769-2026","classification":"Class II"}],"reason":"Due to device not having FDA Clearance","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.","nationwide":true,"states":[],"units":"20","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98834","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0736b7bed9365756","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98834","record":[{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98834","recalling_firm":"Prismatik Dentalcraft, Inc.","address_1":"2144 Michelson Dr","address_2":"N/A","postal_code":"92612-1304","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.","recall_number":"Z-2769-2026","product_description":"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).","product_quantity":"20","reason_for_recall":"Due to device not having FDA Clearance","recall_initiation_date":"20260427","center_classification_date":"20260721","report_date":"20260729","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"}]}}