Official recall notice

FDA DeviceClass IINotable

FDA Recall: Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT

Recall date
2026-07-29
FDA class
Class II

Why it was recalled

Hazard

Due to device not having FDA Clearance

Product description

Due to device not having FDA Clearance

Affected products

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

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