The FDA has posted 10 enforcement recalls of oximeter devices since 2025, none of them Class I (most serious). Most recent report: Feb 18, 2026.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Oximeter”). Informational only — verify against the FDA before acting.