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NUANCE PRO Nuance Pro Gel Pillows Mask with headgear, USARecalls & reported problems

Respironics, Inc. · Nuance Pro Gel Pillows Mask with Headgear, USA · 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 00606959012936), received between Aug 24, 2022 and Aug 24, 2022 — 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

  • Skin Inflammation/ Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION FROM A USER THAT HIS NUANCE NASAL PILLOWS WERE CAUSING IRRITATION AND A BURNING SENSATION. USER STATED HE DID NOT WASH THE MASK PRIOR TO USAGE. THE USER ALSO STATED HE USES A DISINFECTANT CPAP CLEANER SPRAY TO CLEAN HIS EQUIPMENT. THE USER VISITED HIS PRIMARY CARE DOCTOR AND WAS PRESCRIBED ANTIBIOTICS. THE USER NO LONGER HAS THIS MASK AND WILL NOT BE RETURNING IT FOR EVALUATION. THIS MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THE PRODUCT INSTRUCTIONS STATE: HAND WASH THE ENTIRE MASK BEFORE FIRST USE. THE NON-FABRIC PARTS SHOULD BE HAND WASHED DAILY. HAND WASH IN WARM WATER WITH A MILD LIQUID DISH WASHING DETERGENT. RINSE THOROUGHLY. AIR DRY COMPLETELY BEFORE USE. THE WARNINGS STATE: · DO NOT USE BLEACH, ALCOHOL, CLEANING SOLUTIONS CONTAINING BLEACH OR ALCOHOL, OR CLEANING SOLUTIONS CONTAINING CONDITIONERS OR MOISTURIZERS. ANY DEVIATION FROM THESE INSTRUCTIONS MAY IMPACT

    Patient problems: Skin Inflammation/ Irritation

    MAUDE report 15282949 ↗

Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices

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Sources and updates

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