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Draeger Medical Recalls
78 recalls on record · March 20, 2013 to December 25, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 1, 2023Medical DevicesFDA
Draeger Medical, Inc. recalls NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Hazard: 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.
June 22, 2022Medical DevicesFDA
Draeger Medical, Inc. recalls Drager SafeStar 55, Catalog No. MP01790
Hazard: Possible occlusion of filters due to manufacturing error.
April 13, 2022Medical DevicesFDA
Draeger Medical, Inc. recalls Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.
Hazard: Cybersecurity Improvement Action-not equipped against potential cyber security threats
April 13, 2022Medical DevicesFDA
Draeger Medical, Inc. recalls Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal pa
Hazard: Cybersecurity Improvement Action-not equipped against potential cyber security threats
January 26, 2022Medical DevicesFDA
Draeger Medical, Inc. recalls Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Hazard: 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.
October 20, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.
Hazard: 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
October 20, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal
Hazard: 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
June 9, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who requ
Hazard: 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
June 9, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who requ
Hazard: 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
June 9, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require
Hazard: 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
June 9, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require
Hazard: 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
March 17, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing cir
Hazard: 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.
March 17, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing ci
Hazard: 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.
March 17, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circu
Hazard: 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.
March 17, 2021Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing
Hazard: 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.
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circ
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circ
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia Sets without a Water trap: Breat
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets without a Water trap: Breat
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathin
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing ci
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing ci
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
January 30, 2019Medical DevicesFDA
Draeger Medical, Inc. recalls VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circui
Hazard: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
June 27, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adul
Hazard: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
June 27, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apo
Hazard: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
June 27, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operatin
Hazard: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
June 27, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operati
Hazard: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
June 27, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in oper
Hazard: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
June 6, 2018Medical DevicesFDA
Draeger Medical, Inc. recalls Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified me
Hazard: The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.