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Draeger Medical, Inc.

Draeger Medical, Inc. Recalls

All product recalls associated with Draeger Medical, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 84 recalls

Draeger Medical, Inc.: VentStar Watertrap (N) 180, MP00363

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

FDAApr 17, 2023Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Ventstar Coax 180, MP03374

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

FDAApr 17, 2023Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: VentStar Anesthesia (N) 180, MP00333

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

FDAApr 17, 2023

1 234 5

Page 3 of 5Next

Nationwide

• Draeger Medical, Inc.

Draeger Medical Systems, Inc.: Draeger Infinity M300 and M300+, for use with the ICS to ...

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

FDAApr 5, 2023Nationwide• Draeger Medical Systems, Inc.

Draeger Medical Systems, Inc.: Draeger Infinity CentralStation (ICS), centralized monito...

FDAApr 5, 2023Nationwide• Draeger Medical Systems, Inc.

Draeger Medical, Inc.: NovaStar TS, Standard elbow, Reusable, Material Numbers M...

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

FDAJan 23, 2023Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numb...

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

FDAJan 23, 2023Nationwide• Draeger Medical, Inc.

Draeger Medical Systems, Inc.: Draeger Globe-Trotter and Globe-Trotter IC, Model numbers...

The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

FDAMay 20, 2022DE, IN• Draeger Medical Systems, Inc.

Draeger Medical, Inc.: Drager SafeStar 55, Catalog No. MP01790

Possible occlusion of filters due to manufacturing error.

FDAMay 16, 2022Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Babylog VN500 Ventilator with Software 2.51.01 and Lower-...

Cybersecurity Improvement Action-not equipped against potential cyber security threats

FDAFeb 14, 2022Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Evita V500 Ventilator with Software 2.51.01 and Lower - i...

Cybersecurity Improvement Action-not equipped against potential cyber security threats

FDAFeb 14, 2022Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Draeger Fabius MRI Anesthesia Machine, Catalog Number 860...

26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.

FDADec 16, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Babylog VN500 Ventilator with Installed CO2 Measurement O...

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

FDASep 10, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Evita V500 Ventilator with Installed CO2 Measurement Opti...

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

FDASep 10, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Critical Care Ventilator, Catalog Number(s): 8422300: Evi...

Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

FDAApr 16, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: VentStar Anesthesia (N) 180 - Drager Breathing Circuits/A...

Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.

FDAJan 29, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: VentStar Watertrap (N) 180-Drager Breathing Circuits/Anes...

Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.

FDAJan 29, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: VentStar Basic (N) 180- Drager Breathing Circuits/Anesthe...

Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.

FDAJan 29, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesth...

Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.

FDAJan 29, 2021Nationwide• Draeger Medical, Inc.

Draeger Medical, Inc.: Delta/Delta XL Monitors with Omega S Package

monitor is rebooting/resetting

FDANov 9, 2009CA, CO, CT +7 more• Draeger Medical, Inc.