The FDA has posted 6 enforcement recalls of non-continuous (respirator) ventilator devices since 2025, including 5 Class I (most serious) recalls. Most recent report: Sep 30, 2026.
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…
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…
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Devices may possess a programming error resulting in an incorrect device configuration.
Devices may possess a programming error resulting in an incorrect device configuration.
Devices may possess a programming error resulting in an incorrect device configuration.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Ventilator, Non-Continuous (Respirator)”). Informational only — verify against the FDA before acting.