Ventilator, Non-Continuous (Respirator)
FDA adverse event reports and recall history for ventilator, non-continuous (respirator) (product code BZD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 289,187
- Deaths
- 4,568
- Injuries
- 53,620
- Malfunctions
- 230,805
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-15Open, ClassifiedLabeling Change Control
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
- 2025-08-08Open, ClassifiedProcess control
DreamStation Auto CPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-08-08Open, ClassifiedProcess control
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-08-08Open, ClassifiedProcess control
DreamStation Auto. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2024-04-01Open, ClassifiedDevice Design
Mojo Full Face with Headgear, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
- 2024-04-01Open, ClassifiedDevice Design
Mojo Non Vented Full Face Mask with Headgear, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
- 2024-04-01Open, ClassifiedDevice Design
Mojo 2 Full Face Vented Mask, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
- 2024-04-01Open, ClassifiedDevice Design
Mojo 2 Full Face Non Vented Mask, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
- 2024-04-01Open, ClassifiedDevice Design
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
- 2024-04-01Open, ClassifiedDevice Design
iQ 2 Nasal Vented Mask
Update to contraindications and warning language due to CPAP masks containing magnets.
Monitor ventilator, non-continuous (respirator) automatically
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