The Recall Desk

Manufacturer

Draeger Medical, Inc.

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

What the numbers show

Total
78
Critical
8
Severe
42
Most recent
2024-12-25

Of the 78 recalls from Draeger Medical, Inc. we have scored against our rubric, 8 (10%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 42 (54%) 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.

26–50 of 78

  • SevereFDA (Devices)·Z-1458-2023·2023-05-24

    Anesthesia Set Coax 180 Breathing Circuit Connection Risk

    Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.

    Product
    Anesthesia Set Coax 180, MP03384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2023·2023-05-24

    Anesthesia Ventilator Breathing Circuit Connections May Detach During Use

    Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.

    Product
    VentStar Anesthesia WT (P)180, MP00374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1451-2023·2023-05-24

    VentStar Coax breathing circuit connections recalled for detachment risk

    Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.

    Product
    VentStar Coax (P) 150, MP00379
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1137-2023·2023-03-01

    NovaStar TS Anti-Asphyxia Valve recalled for magnetic interference risk

    Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.

    Product
    NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2023·2023-03-01

    FDA Recalls NovaStar TS Standard Elbow Reusable Components for Magnet Interference Risk

    Draeger Medical is recalling 893 units of NovaStar TS Standard elbow components due to magnets that could interfere with medical devices and metallic implants.

    Product
    NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1211-2022·2022-06-22

    Drager SafeStar 55 Medical Devices Recalled for Possible Filter Occlusion

    Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.

    Product
    Drager SafeStar 55, Catalog No. MP01790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2022·2022-04-13

    Draeger Evita V500 Ventilator Cybersecurity Vulnerability Affects Patient Safety

    Draeger Medical is recalling Evita V500 ventilators due to cybersecurity vulnerabilities that could potentially compromise device functionality. Affected units require software remediation.

    Product
    Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2022·2022-04-13

    Draeger Babylog VN500 Ventilators Recalled for Cybersecurity Vulnerability

    Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.

    Product
    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2022·2022-01-26

    Draeger Fabius MRI Anesthesia Machines recalled due to misrouted oxygen hoses

    Draeger Medical recalls 26 Fabius MRI Anesthesia Machines due to incorrectly routed internal oxygen hoses. The misrouting can cause oxygen flow to deviate from set levels, risking inadequate patient oxygenation.

    Product
    Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2022·2021-10-20

    Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss

    Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.

    Product
    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2022·2021-10-20

    Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption

    A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.

    Product
    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2021·2021-06-09

    Critical care ventilators recalled for software defects affecting alarm and operation

    Draeger Medical is recalling critical care ventilators due to software defects that can cause the device to restart, display incorrect oxygen alarms, and suspend weaning protocols. No patient injuries have been reported.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2021·2021-06-09

    Draeger Evita V800 Ventilator Recalled for Multiple Software Defects

    Draeger Medical is recalling the Evita V800 critical care ventilator due to three unrelated software defects affecting ventilation delivery and alarm functionality.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2021·2021-06-09

    Babylog VN800 Critical Care Ventilator Recalled for Software Malfunctions

    Draeger Medical is recalling critical care ventilators due to software defects causing unexpected unit restarts, incorrect oxygen level alarms, and suspension of weaning therapy. Twelve units were distributed nationwide.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2021·2021-06-09

    Draeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects

    Draeger Medical is recalling Babylog VN600 ventilators due to three software issues: unexpected unit restarts, incorrect oxygen-level alarms, and failure of the automated weaning protocol. These defects could affect patient care and safety.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1177-2021·2021-03-17

    Draeger VentStar Anesthesia Breathing Circuits Recalled for Detachment Risk

    Draeger Medical is recalling VentStar Anesthesia breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2021·2021-03-17

    Draeger VentStar Watertrap Breathing Circuits Recalled for Detachment Risk

    Draeger Medical is recalling 150 units of VentStar Watertrap (N) 180 breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2021·2021-03-17

    Dräger ID Circuit Basic Breathing Circuits Recalled for Detachment Risk

    Dräger Medical is recalling ID Circuit Basic (N) 180 breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2021·2021-03-17

    Dräger VentStar Basic Breathing Circuits Recalled for Detachment Risk

    Draeger Medical is recalling 1,525 VentStar Basic breathing circuits because a Y-piece may detach, causing a leak that hinders patient ventilation.

    Product
    VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0737-2019·2019-01-30

    Draeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error

    Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.

    Product
    VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0739-2019·2019-01-30

    Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error

    Draeger Medical is recalling 75 units of VentStar Basic (P) 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.

    Product
    VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0741-2019·2019-01-30

    Draeger Medical Recalls 10 VentStar Anesthesia Breathing Circuits

    Draeger Medical is recalling 10 units of VentStar Anesthesia WT(P) 180 breathing circuits due to incorrect pre-assembly that could cause incorrect connections.

    Product
    VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthes
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0738-2019·2019-01-30

    Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error

    Draeger Medical is recalling 525 units of VentStar Basic (P) 180 breathing circuits because they were incorrectly pre-assembled, posing a risk of incorrect connection or short circuiting.

    Product
    VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0740-2019·2019-01-30

    Draeger Medical Recalls VentStar Watertrap Breathing Circuits Due to Assembly Error

    Draeger Medical is recalling 25 units of VentStar Watertrap (P) 180 breathing circuits because they were incorrectly pre-assembled, posing a risk of incorrect connection.

    Product
    VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia
    Category
    Medical Device
    Distribution
    12 states