FDA recall Z-2769-2026

Product

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).

Reason for recall

Due to device not having FDA Clearance

Distribution

U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.

Key facts

Status

Ongoing

Initiation date

2026-04-27

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2769-2026