Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–9 of 9 recalls
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.