Device, Anti-Snoring
FDA adverse event reports and recall history for device, anti-snoring (product code LRK), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 2,628
- Deaths
- 1
- Injuries
- 728
- Malfunctions
- 1,878
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-07-21Open, ClassifiedProcess control
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).
Due to device not having FDA Clearance
- 2025-12-18Open, ClassifiedNo Marketing Application
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
- 2018-05-29TerminatedDevice Design
Respire Pink Series EF+ Oral Sleep Apnea Device.
Potential for device breakage during use
- 2018-05-29TerminatedDevice Design
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Potential for device breakage during use
- 2018-05-29TerminatedDevice Design
Respire Pink+ Hard Oral Sleep Apnea Device
Potential for device breakage during use
- 2018-05-29TerminatedDevice Design
Respire Pink H/S Oral Sleep Apnea Device
Potential for device breakage during use
- 2018-05-29TerminatedDevice Design
Respire Pink H/S Oral Sleep Apnea Device
Potential for device breakage during use
- 2009-12-15TerminatedLabeling mix-ups
Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.
Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.
- 2009-12-15TerminatedLabeling mix-ups
Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A.
Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.
- Open, ClassifiedNo Marketing Application
CustMbite, Model Number CBT-SRS-UL
The device was marketed and sold in the US without FDA clearance.
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