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.

51–75 of 78

  • HighFDA (Devices)·Z-0744-2019·2019-01-30

    Draeger ID Circuit Basic 180 Breathing Circuits Recalled for Assembly Defect

    Draeger Medical is recalling 25 units of ID Circuit Basic 180 breathing circuits due to incorrect pre-assembly that may cause connection errors.

    Product
    ID Circuit Basic 180, Catalog Number MP01350 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 w
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0742-2019·2019-01-30

    Draeger Medical Recalls ID Circuit Watertrap Breathing Circuits Due to Assembly Error

    Draeger Medical is recalling 25 units of ID Circuit Watertrap breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.

    Product
    ID Circuit Watertrap (P) 180, Catalog Number MP01341 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-0736-2019·2019-01-30

    Draeger Medical Recalls VentStar Basic 180 Breathing Circuits

    Draeger Medical is recalling 325 units of VentStar Basic 180 breathing circuits due to incorrect pre-assembly that may cause incorrect connections.

    Product
    VentStar Basic 180, Catalog Number MP00349 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 wit
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0743-2019·2019-01-30

    Draeger Medical Recalls ID Circuit Basic 250 Breathing Circuits

    Draeger Medical is recalling 20 units of ID Circuit Basic 250 breathing circuits due to incorrect pre-assembly that may cause connection errors.

    Product
    ID Circuit Basic 250, Catalog Number MP01348 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 w
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Devices)·Z-2252-2018·2018-06-27

    Draeger Fabius GS MRI Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing death.

    Product
    Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2250-2018·2018-06-27

    Draeger Fabius GS Premium Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

    Product
    Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2253-2018·2018-06-27

    Draeger Apollo Anesthesia Machine Recalled for Potential Hypoxic Gas Delivery

    Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.

    Product
    Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2251-2018·2018-06-27

    Draeger Fabius GS Tiro Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.

    Product
    Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2254-2018·2018-06-27

    Draeger Perseus A500 Anesthesia Machine Recalled for Hypoxic Mixture Risk

    Draeger Medical is recalling 33 Perseus A500 anesthesia machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

    Product
    Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2018·2018-06-06

    Draeger Carina Ventilator Recalled Due to Valve Assembly Corrosion Risk

    Draeger Medical is recalling eight Carina Ventilators because valve assembly corrosion may contaminate breathing gas.

    Product
    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1483-2018·2018-05-16

    Draeger Fabius Tiro Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 26 Fabius Tiro anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted ga
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1482-2018·2018-05-16

    Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 27 Fabius GS Premium anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally moun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1484-2018·2018-05-16

    Draeger Fabius Tiro M Anesthesia Machine Recalled for Ventilator Failure Risk

    Draeger Medical is recalling one Fabius Tiro M anesthesia machine because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2018·2018-05-16

    Draeger Fabius MRI Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling eight Fabius MRI anesthesia machines because automatic or manual ventilation may fail if the motor position is disturbed or the ventilator cover is damaged.

    Product
    Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2215-2016·2016-08-10

    Draeger Recalls Oxylog 3000 Pediatric Patient Circuits Due to Leakage

    Draeger Medical is recalling Oxylog 3000 disposable pediatric patient circuits because isolated episodes of leakage were found at the check valve.

    Product
    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2016·2016-08-03

    Draeger Babytherm Infant Warmers Recalled for Skin Temperature Mode Risk

    Draeger Medical is recalling 1,599 Babytherm infant warmers due to a risk associated with operating the device in skin temperature mode without a patient connected.

    Product
    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2016·2016-06-01

    Draeger D-Vapor Anesthesia Vaporizers Recalled for Anesthetic Agent Release

    Draeger Medical is recalling D-Vapor and D-Vapor 3000 anesthesia vaporizers because they may release desflurane during filling, posing an eye irritation risk.

    Product
    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0827-2016·2016-03-02

    Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect

    Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.

    Product
    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0692-2016·2016-02-10

    Draeger Oxylog 3000 Ventilators Recalled for Software Error

    Draeger Medical is recalling Oxylog 3000 and Oxylog 3000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0691-2016·2016-02-10

    Draeger Oxylog 2000 Plus Ventilator Recalled for Malfunction

    Draeger Medical is recalling Oxylog 2000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2016·2015-12-30

    Draeger Recalls Optional PS500 Power Supply Units for Ventilators

    Draeger Medical is recalling 2,422 optional PS500 power supply units for Evita V500 and Babylog VN500 ventilators due to unexpectedly short battery run times.

    Product
    Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0360-2016·2015-12-23

    Draeger Perseus A500 Anesthesia Workstation Recalled for Power Switch Failure

    Draeger Medical is recalling 34 Perseus A500 Anesthesia Workstations because the main power switch may fail during use, causing ventilation or fresh gas delivery failures.

    Product
    Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2343-2015·2015-08-26

    Draeger Evita Infinity V500 Ventilator Battery Recall

    Draeger Medical is recalling 2,081 Evita Infinity V500 ventilators because the optional PS500 battery capacity did not last as long as expected.

    Product
    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2271-2015·2015-08-05

    Draeger Fabius MRI Anesthesia Machine Recalled for Magnetic Field Attraction

    Draeger Medical is recalling 373 Fabius MRI anesthesia machines because their parts can be loosened by the magnetic field of MRI equipment.

    Product
    Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2014·2014-04-16

    Draeger Recalls Reusable Latex Breathing Bags Due to Allergic Reaction Incident

    Draeger Medical is recalling reusable latex breathing bags and test lungs after a user reported an acute allergic reaction. The product is distributed nationwide.

    Product
    Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering me
    Category
    Medical Device
    Distribution
    Distributed nationwide