Draeger Medical, Inc. FDA Recalls

45 recalls on file across devices, 32 of them Class I and 12 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstatioClass IOct 15, 2024The Atlan anesthesia workstation either indicated a failure	The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a	Class IDevices	Oct 15, 2024
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable ComponenClass IOct 15, 2024The Atlan anesthesia workstation either indicated a failure	The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a	Class IDevices	Oct 15, 2024
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation Class IOct 15, 2024The Atlan anesthesia workstation either indicated a failure	The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a	Class IDevices	Oct 15, 2024
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:Class IOct 15, 2024The Atlan anesthesia workstation either indicated a failure	The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a	Class IDevices	Oct 15, 2024
Dr¿ger Perseus A500 Anesthesia WorkstationClass IMar 20, 2024Unexpected shutdown while operating on battery power.	Unexpected shutdown while operating on battery power.	Class IDevices	Mar 20, 2024
Carina Sub-Acute Care VentilatorClass IJul 12, 2023Presence of polyether polyurethane (PE-PUR) and emission of	Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable	Class IDevices	Jul 12, 2023
Oxylog 3000 Plus emergency and transport ventilatorClass IJun 12, 2023Draeger has become aware of instances where the device stopp	Draeger has become aware of instances where the device stopped working when in use when transitioning from bat	Class IDevices	Jun 12, 2023
VentStar Watertrap (P) 180, MP00361Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Set2Go Ventilation 12 (A), MP07968Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Seattle PAP Plus, MP02260Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Anesthesia Set Coax 180, MP03384Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Anesthesia Circuit Kit Coax 1, MP02730Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
ID Coax 180, MP03375Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
ID Circuit Basic (P) 180, MP01340Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Watertrap (P) 180 w/oLL, MP00362Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Basic (P)180, MP00351Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Watertrap (N) 180, MP00363Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Ventstar Coax, MP03373Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar breathing bag Set (P) 110, MP00384Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Basic (P)250, MP00352Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Ventstar Coax 180, MP03374Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Anesthesia Circuit Kit Coax 3, MP02732Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Bag Set (N) 110, MP00383Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Basic (N) 180, MP00353Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Ventstar Coax 230, MP03376Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Coax (P) 150, MP00379Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Anesthesia WT (P)180, MP00374Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
Anesthesia Circuit Kit Coax HEPA, MP17102Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
VentStar Anesthesia (N) 180, MP00333Class IApr 17, 2023Glued connections of the breathing circuit can become loose	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial	Class IDevices	Apr 17, 2023
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)Class IJan 23, 2023The magnets used in the swivel frame/tube set and the headge	The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted a	Class IDevices	Jan 23, 2023
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)Class IJan 23, 2023The magnets used in the swivel frame/tube set and the headge	The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted a	Class IDevices	Jan 23, 2023
Drager SafeStar 55, Catalog No. MP01790Class IMay 16, 2022Possible occlusion of filters due to manufacturing error.	Possible occlusion of filters due to manufacturing error.	Class IDevices	May 16, 2022
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.Class IIFeb 14, 2022Cybersecurity Improvement Action-not equipped against potent	Cybersecurity Improvement Action-not equipped against potential cyber security threats	Class IIDevices	Feb 14, 2022
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal paClass IIFeb 14, 2022Cybersecurity Improvement Action-not equipped against potent	Cybersecurity Improvement Action-not equipped against potential cyber security threats	Class IIDevices	Feb 14, 2022
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300Class IIDec 16, 202126 Fabius MRI Anesthesia machines were distributed with inte	26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and	Class IIDevices	Dec 16, 2021
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.Class IISep 10, 2021Software 2.51 and Lower with Installed CO2 Measurement Optio	Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief	Class IIDevices	Sep 10, 2021
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatalClass IISep 10, 2021Software 2.51 and Lower with Installed CO2 Measurement Optio	Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief	Class IIDevices	Sep 10, 2021
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who requireClass IIApr 16, 2021Three separate and unrelated problems attributed to the soft	Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog V	Class IIDevices	Apr 16, 2021
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who requireClass IIApr 16, 2021Three separate and unrelated problems attributed to the soft	Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog V	Class IIDevices	Apr 16, 2021
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who requClass IIApr 16, 2021Three separate and unrelated problems attributed to the soft	Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog V	Class IIDevices	Apr 16, 2021
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who requClass IIApr 16, 2021Three separate and unrelated problems attributed to the soft	Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog V	Class IIDevices	Apr 16, 2021
VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuClass IIJan 29, 2021Y-piece may become detached from the ventilation hose either	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak	Class IIDevices	Jan 29, 2021
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing cirClass IIJan 29, 2021Y-piece may become detached from the ventilation hose either	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak	Class IIDevices	Jan 29, 2021
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: BreathingClass IIJan 29, 2021Y-piece may become detached from the ventilation hose either	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak	Class IIDevices	Jan 29, 2021
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing ciClass IIJan 29, 2021Y-piece may become detached from the ventilation hose either	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak	Class IIDevices	Jan 29, 2021