Maquet Critical Care AB

3 FDA enforcement actions

3 Total Recalls

3 Class I

0 Class II

0 Class III

Firm Details

Product Types: device
States: N/A

All Recalls

Class I: Dangerous 05/30/2025 device

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.
Class I: Dangerous 05/30/2025 device

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.
Class I: Dangerous 05/30/2025 device

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.