Draeger Medical recalls
Draeger Medical appears in 78 official U.S. recall notices indexed by RecallRadar, most recently on 2024-12-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 78 |
|---|---|
| Published | 2013-03-20 to 2024-12-25 |
| By agency | FDA Device (78) |
| By classification | Class I (53), Class II (25) |
| By status | terminated (66), ongoing (12) |
| Distribution named in notices | AL, CA, CO, CT, FL, IL, KY, MA, ME, MI, MN, NJ, NV, NY, OH, PA, SC, SD, TX, US, WA, WI |
Recalls
- Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthe…
FDA Device · Class I · 2024-12-25 · Draeger Medical
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anest…
FDA Device · Class I · 2024-12-25 · Draeger Medical
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
FDA Device · Class I · 2024-11-20 · Draeger Medical
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
FDA Device · Class I · 2024-11-20 · Draeger Medical
Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. - Dr¿ger Perseus A500 Anesthesia Workstation
FDA Device · Class I · 2024-04-24 · Draeger Medical
Reason: Unexpected shutdown while operating on battery power. - Carina Sub-Acute Care Ventilator
FDA Device · Class I · 2023-08-30 · Draeger Medical
Reason: Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients. - Oxylog 3000 Plus emergency and transport ventilator
FDA Device · Class I · 2023-07-19 · Draeger Medical
Reason: Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation. - VentStar Basic (P)180, MP00351
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - ID Coax 180, MP03375
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Seattle PAP Plus, MP02260
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - ID Circuit Basic (P) 180, MP01340
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Basic (N) 180, MP00353
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Watertrap (N) 180, MP00363
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Set2Go Ventilation 12 (A), MP07968
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Anesthesia Circuit Kit Coax HEPA, MP17102
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Anesthesia Circuit Kit Coax 1, MP02730
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Anesthesia Circuit Kit Coax 3, MP02732
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Anesthesia WT (P)180, MP00374
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar breathing bag Set (P) 110, MP00384
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Anesthesia (N) 180, MP00333
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Coax (P) 150, MP00379
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Watertrap (P) 180, MP00361
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Watertrap (P) 180 w/oLL, MP00362
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Basic (P)250, MP00352
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Ventstar Coax 230, MP03376
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Ventstar Coax, MP03373
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Anesthesia Set Coax 180, MP03384
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - VentStar Bag Set (N) 110, MP00383
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - Ventstar Coax 180, MP03374
FDA Device · Class I · 2023-05-24 · Draeger Medical
Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. - NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
FDA Device · Class I · 2023-03-01 · Draeger Medical
Reason: 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. - NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
FDA Device · Class I · 2023-03-01 · Draeger Medical
Reason: 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. - Drager SafeStar 55, Catalog No. MP01790
FDA Device · Class I · 2022-06-22 · Draeger Medical
Reason: Possible occlusion of filters due to manufacturing error. - Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Numb…
FDA Device · Class II · 2022-04-13 · Draeger Medical
Reason: Cybersecurity Improvement Action-not equipped against potential cyber security threats - 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…
FDA Device · Class II · 2022-04-13 · Draeger Medical
Reason: Cybersecurity Improvement Action-not equipped against potential cyber security threats - Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
FDA Device · Class II · 2022-01-26 · Draeger Medical
Reason: 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… - Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up…
FDA Device · Class II · 2021-10-20 · Draeger Medical
Reason: 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 - Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients
FDA Device · Class II · 2021-10-20 · Draeger Medical
Reason: 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 - Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longe…
FDA Device · Class II · 2021-06-09 · Draeger Medical
Reason: 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. SmartC… - Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or lo…
FDA Device · Class II · 2021-06-09 · Draeger Medical
Reason: 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. SmartC… - Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longe…
FDA Device · Class II · 2021-06-09 · Draeger Medical
Reason: 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. SmartC… - Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or lo…
FDA Device · Class II · 2021-06-09 · Draeger Medical
Reason: 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. SmartC… - ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction…
FDA Device · Class II · 2021-03-17 · Draeger Medical
Reason: 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. - VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduc…
FDA Device · Class II · 2021-03-17 · Draeger Medical
Reason: 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. - VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conductio…
FDA Device · Class II · 2021-03-17 · Draeger Medical
Reason: 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. - VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction o…
FDA Device · Class II · 2021-03-17 · Draeger Medical
Reason: 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. - VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conductio…
FDA Device · Class I · 2019-01-30 · Draeger Medical
Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit - VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduc…
FDA Device · Class I · 2019-01-30 · Draeger Medical
Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit - ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduct…
FDA Device · Class I · 2019-01-30 · Draeger Medical
Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit - VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of res…
FDA Device · Class I · 2019-01-30 · Draeger Medical
Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit - ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of r…
FDA Device · Class I · 2019-01-30 · Draeger Medical
Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit