AMARA AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTLRecalls & reported problems
Respironics, Inc. · AMARA MASK WITH RS FRAME AND HEADGEAR, INTERNATIONAL, LARGE · Class 2
Data updated Oct 18, 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 00606959014992), received between Apr 14, 2021 and Apr 14, 2021 — 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 18, 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.
InjuryApr 14, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
THE MANUFACTURER WAS MADE AWARE OF A USER'S ALLEGATION OF AN ALLERGIC REACTION AROUND THE NOSE DUE TO A PRE-EXISTING SILICON ALLERGY. THE USER WAS REPORTEDLY TREATED WITH AN UNKNOWN TYPE OF "ANTI-ALLERGY MEDICATION". IT IS UNCLEAR IF THE TREATMENT WAS AN OVER THE COUNTER (OTC ) TREATMENT OR A PRESCRIPTION MEDICATION. THE USER IS REPORTED TO HAVE STOPPED USING THE MASK AND IS NO LONGER UNDERGOING ANY TREATMENT FOR THE ALLERGIC REACTION. THERE IS NO REPORT OF A SERIOUS OR PERMANENT INJURY. THE USER REPORTEDLY WAS GIVEN A MASK THAT DID NOT CONTAIN SILICON. THE MANUFACTURER ATTEMPTED TO GATHER ADDITIONAL INFORMATION FROM THE REPORTER WITHOUT SUCCESS. IT REMAINS UNKNOWN IF THE TREATMENT WAS AN OTC OR PRESCRIPTION MEDICATION. NO LOT NUMBER WAS PROVIDED, AND NO PRODUCT WAS RETURNED FOR INVESTIGATION. LABELING INCLUDED WITH THE MASK WARNS THE USER "SOME USERS MAY EXPERIENCE SKIN REDNESS, IRRITATION, OR DISCOMFORT. IF THIS HAPPENS, DISCONTINUE USE AND CONTACT YOUR HEALTHCARE PROFESSIONAL." THE USER IS ALSO ADVISED TO HAND WASH THE MASK BEFORE FIRST USE AND DAILY WITH A MILD DETERGENT, RINSE THOROUGHLY, AND ALLOW TO AIR DRY. THIS MASK MEETS ALL RELEVANT STANDARDS FOR BIO-COMPATIBILITY. THE M
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11667512 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
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- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
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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