Telford, PA, United States
Draeger Medical, Inc. recalls
17 recalls recorded since 2018, most recently on 15 October 2024. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls17
Ongoing (FDA)8
Terminated or completed9
Class I (FDA)10
Ongoing Class I Medical devices
- Recall started
- 15 October 2024
- 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.
- Distribution
- No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0668-2025, Z-0667-2025
- Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
- Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Ongoing Class I Medical devices
- Recall started
- 15 October 2024
- 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.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0305-2025, Z-0304-2025
- Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
- Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Ongoing Class I Medical devices
- Recall started
- 20 March 2024
- Reason
- Unexpected shutdown while operating on battery power.
- Distribution
- Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-se- S, Bulgaria, Canada, Chili, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, French
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1512-2024
- Dr¿ger Perseus A500 Anesthesia Workstation
Ongoing Class I Medical devices
- Recall started
- 12 July 2023
- 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.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2248-2023
- Carina Sub-Acute Care Ventilator
Ongoing Class I Medical devices
- Recall started
- 12 June 2023
- Reason
- Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
- Distribution
- Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra, Angola, Antigua/Barbados, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bolivia, Brunei Dar-es-S, Bulgaria, Burkina-Faso, Cambodia, Canada, Cayman Islands, Chile, China, Christmas Island, Columbia, Congo
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2018-2023
- Oxylog 3000 Plus emergency and transport ventilator
Terminated Class I Medical devices
- Recall started
- 17 April 2023
- Terminated
- 3 September 2024
- Reason
- Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- Distribution
- Domestic: US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1440-2023, Z-1459-2023, Z-1439-2023, Z-1444-2023, Z-1458-2023, Z-1449-2023, Z-1442-2023, Z-1447-2023, Z-1454-2023, Z-1446-2023, Z-1441-2023, Z-1453-2023 and 10 more
- VentStar Basic (P)180, MP00351
- Set2Go Ventilation 12 (A), MP07968
- Seattle PAP Plus, MP02260
- VentStar Anesthesia WT (P)180, MP00374
- Anesthesia Set Coax 180, MP03384
- VentStar Watertrap (N) 180, MP00363
- VentStar Watertrap (P) 180, MP00361
- VentStar Anesthesia (N) 180, MP00333
- and 14 more product lines
Ongoing Class I Medical devices
- Recall started
- 23 January 2023
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1138-2023, Z-1137-2023
- NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
- NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Ongoing Class I Medical devices
- Recall started
- 16 May 2022
- Reason
- Possible occlusion of filters due to manufacturing error.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NV, NY, OH, PA, TN, TX, WA, and WV. The countries of Austria, Belgium, Bulgaria, Canada, Columbia, Croatia, Czech Republic, Denmark, France, Germany, India, Indonesia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1211-2022
- Drager SafeStar 55, Catalog No. MP01790
Terminated Class II Medical devices
- Recall started
- 14 February 2022
- Terminated
- 7 January 2025
- Reason
- Cybersecurity Improvement Action-not equipped against potential cyber security threats
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0870-2022, Z-0871-2022
- Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
- 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) bodyweig
Terminated Class II Medical devices
- Recall started
- 16 December 2021
- Terminated
- 17 April 2023
- 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 flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.
- Distribution
- US Nationwide distribution in the states of NY, PA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0501-2022
- Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Ongoing Class II Medical devices
- Recall started
- 10 September 2021
- 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
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0109-2022, Z-0108-2022
- 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)
- Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Terminated Class II Medical devices
- Recall started
- 16 April 2021
- Terminated
- 6 February 2024
- 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. SmartCare/PS (SC/PS) suspends weaning
- Distribution
- US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1692-2021, Z-1690-2021, Z-1691-2021, Z-1693-2021
- 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.
- 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.
- 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.
- 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.
Terminated Class II Medical devices
- Recall started
- 29 January 2021
- Terminated
- 1 November 2021
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1180-2021, Z-1179-2021, Z-1177-2021, Z-1178-2021
- 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. Inten
- 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. Inte
- 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. I
- 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. Intende
Terminated Class I Medical devices
- Recall started
- 21 December 2018
- Terminated
- 16 April 2019
- Reason
- Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
- Distribution
- US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0744-2019, Z-0740-2019, Z-0737-2019, Z-0742-2019, Z-0739-2019, Z-0736-2019, Z-0738-2019, Z-0743-2019, Z-0741-2019
- 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. Intend
- 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.
- 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
- 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 patien
- 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. Inte
- 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
- 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. Inte
- 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. Intend
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 24 May 2018
- Terminated
- 12 May 2020
- Reason
- 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.
- Distribution
- US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2254-2018, Z-2251-2018, Z-2250-2018, Z-2252-2018, Z-2253-2018
- 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 s
- 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 p
- 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 ga
- 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 pi
- 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 vap
Terminated Class II Medical devices
- Recall started
- 26 April 2018
- Terminated
- 7 September 2018
- Reason
- 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.
- Distribution
- Distributed to the states of CT, IL, MN, NV, SD, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1954-2018
- Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Terminated Class I Medical devices
- Recall started
- 1 March 2018
- Terminated
- 16 April 2019
- Reason
- The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
- Distribution
- US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1481-2018, Z-1482-2018, Z-1483-2018, Z-1484-2018
- 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 b
- 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 sup
- 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
- 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 supplie
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.