Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 4,932 recalls
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state.…
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state.…
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Software issue may cause the ruler measurement to be inaccurate.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Kits contain a potentially contaminated component which were recalled by the manufacturer