Ventilator, Non-Continuous (Respirator)
FDA adverse event reports and recall history for ventilator, non-continuous (respirator) (product code BZD), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 304,206
- Deaths
- 4,571
- Injuries
- 53,746
- Malfunctions
- 245,678
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-18Open, ClassifiedDevice Design
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
- 2026-09-18Open, ClassifiedDevice Design
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
- 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.
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