Respire Pink AT EF SPAT030USRecalls & reported problems
Respire Medical Holdings LLC · Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851861007253), received between Jan 25, 2023 and Jan 25, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 25, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
THE PATIENT HAD AN ALLERGIC REACTION TO METAL HINGES, SPECIFICALLY BURNING SENSATION THAT TOOK 6 HOURS TO GO AWAY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16242613 ↗
Other Device, Anti-Snoring devices
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- Prosomnus IA MonogramProsomnus Sleep Technologies · Device, Anti-Snoring3 reports
- Pink Series - H/S SP020USRespire Medical Holdings LLC · Device, Anti-Snoring3 reports
- AIRvance® 76353200MMedtronic Xomed, Inc. · Device, anti-snoring2 reports
- Flex F3000Somnomed, Inc. · Device, Anti-Snoring2 reports
- SICAT OPTISLEEP 10401SiCAT GmbH & Co. KG · Device, Anti-Snoring1 report
- Pink Series - Hard SP000USRespire Medical Holdings LLC · Device, Anti-Snoring1 report
- Pink Series - EF SP030USRespire Medical Holdings LLC · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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