The Recall Desk

Manufacturer

Draeger Medical Systems, Inc.

12 recalls in our database name Draeger Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
2
Most recent
2025-02-05

Of the 12 recalls from Draeger Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (17%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • HighFDA (Devices)·Z-1066-2025·2025-02-05

    Infinity Central Station speakers may fail to produce critical patient alarms

    Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.

    Product
    Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2024·2024-07-03

    Infinity M500 Cardiac Monitor Poses Electrical Shock Risk

    Draeger recalls 34,102 Infinity M500 monitoring systems due to electrical safety noncompliance. The devices pose a potential risk of electrical shock, burns, and cardiac arrhythmia.

    Product
    Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2023·2023-06-28

    Draeger Resuscitaire Warmer Scale May Display Inaccurate Weight Values

    Draeger Medical Systems is recalling 936 units of Softbed Resuscitaire and Birthing Room Warmer models with optional scales that may display inaccurate weight readings, affecting clinical care for newborns.

    Product
    Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2023·2023-05-03

    Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect

    Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.

    Product
    Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2023·2023-05-03

    Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings

    Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.

    Product
    Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2022·2022-07-20

    Neonatal Transport System Oxygen Supply Component Pressure-Rating Defect

    Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.

    Product
    Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2046-2018·2018-06-13

    Draeger Jaundice Meter JM-103 Recalled for Measurement Display Misinterpretation

    Draeger Medical Systems is recalling the Jaundice Meter JM-103 because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2047-2018·2018-06-13

    Draeger Jaundice Meter JM-105 Recalled for Misinterpreted Display Readings

    Draeger Medical Systems is recalling 6,711 Draeger Jaundice Meter JM-105 devices because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1440-2014·2014-04-16

    Draeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault

    Draeger Medical Systems is recalling three Oxylog 3000 plus ventilators because the control knobs may interrupt contact, causing the device to stop ventilation.

    Product
    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2014·2014-04-09

    Draeger PS500 Power Supply Unit Recalled Due to Reduced Battery Capacity

    Draeger Medical Systems is recalling 1,544 PS500 Power Supply Units because the battery capacity did not last as long as expected.

    Product
    Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2014·2014-01-22

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.

    Product
    Draeger Infinity Acute Care System Monitoring Solution
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1950-2012·2012-07-18

    Drager PT 4000 Phototherapy System Recalled for Incorrect Fuse Rating

    Draeger Medical Systems is recalling 65 Drager PT 4000 Phototherapy Systems because they contain a 16 Amp fuse instead of the specified 1.6 Amp fuse, posing a risk of overheating.

    Product
    Drager PT 4000 Phototherapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide