Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 421–432 of 595 recalls
This device does not indicate for use in patients with respiratory failure.
This device does not indicate for use in patients with respiratory failure.
This device does not indicate for use in patients with respiratory failure.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone.…
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values.…