Respire Pink+ Hard SPP000USRecalls & reported problems
Respire Medical Holdings LLC · Intraoral device for the treatment of snoring and mild to moderate obstructive sleep apnea · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851861007130), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2018Break; Break
A RESPIRE MEDICAL CUSTOMER SERVICE REPRESENTATIVE SPOKE WITH A DOCTOR'S OFFICE STAFF MEMBER AND WAS TOLD THAT THE PINK+ HINGE BROKE INTRAORALLY WHEN PATIENT WAS SLEEPING. THERE WAS NO INJURY TO THE PATIENT
Patient problems: Discomfort
MAUDE report 7595429 ↗
Other Device, Anti-Snoring devices
- Prosomnus IA MonogramProsomnus Sleep Technologies · Device, Anti-Snoring3 reports
- Pink Series - H/S SP020USRespire Medical Holdings LLC · Device, Anti-Snoring3 reports
- ProSomnus EVO Sleep and Snore DeviceProsomnus Sleep Technologies · Device, Anti-Snoring3 reports
- Flex F3000Somnomed, Inc. · Device, Anti-Snoring2 reports
- AIRvance® 76353200MMedtronic Xomed, Inc. · Device, anti-snoring2 reports
- The Panthera Anti-Snoring Device 1Panthera Dentaire Inc · Device, Anti-Snoring1 report
- Pink Series - EF SP030USRespire Medical Holdings LLC · Device, Anti-Snoring1 report
- SICAT OPTISLEEP 10401SiCAT GmbH & Co. KG · Device, Anti-Snoring1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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