Sourcing & Management of Health Products - Updates

Recalling US FDA Safety Communication on Pulse Oximeter Accuracy and Limitations

18 February 2022

The U.S. Food and Drug Administration (FDA) has recently published a safety communication on Pulse Oximeter Accuracy and Limitations.

While the COVID-19 pandemic has caused an increase in the use of pulse oximeters, a recent report (Sjoding et al.) suggests that the devices may be less accurate in people with dark skin pigmentation.

The US FDA communication recalls that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered.