Draeger, Inc.

19 FDA enforcement actions

19 Total Recalls

19 Class I

0 Class II

0 Class III

Firm Details

Product Types: device
States: PA

All Recalls

Class I: Dangerous 11/24/2025 device

A certain component of affected devices was not delivered within specification and contained impurities.
Class I: Dangerous 11/24/2025 device

A certain component of affected devices was not delivered within specification and contained impurities.
Class I: Dangerous 11/10/2025 device

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I: Dangerous 11/10/2025 device

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I: Dangerous 11/10/2025 device

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I: Dangerous 11/10/2025 device

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I: Dangerous 09/09/2025 device

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class I: Dangerous 09/09/2025 device

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class I: Dangerous 06/16/2025 device

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Class I: Dangerous 06/16/2025 device

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Class I: Dangerous 06/16/2025 device

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Class I: Dangerous 06/16/2025 device

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Class I: Dangerous 03/12/2025 device

The potential for cracks forming in the breathing circuit hose.
Class I: Dangerous 03/12/2025 device

The potential for cracks forming in the breathing circuit hose.
Class I: Dangerous 03/12/2025 device

The potential for cracks forming in the breathing circuit hose.
Class I: Dangerous 03/12/2025 device

The potential for cracks forming in the breathing circuit hose.
Class I: Dangerous 03/12/2025 device

The potential for cracks forming in the breathing circuit hose.
Class I: Dangerous 03/12/2025 device

The potential for cracks forming in the breathing circuit hose.
Class I: Dangerous 03/12/2025 device

The potential for cracks forming in the breathing circuit hose.

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.