Draeger Medical, Inc.: FDA recalls

FDA enforcement reports name Draeger Medical, Inc. as the recalling firm in 30 events. The events have 78 product records. The recalls started from 2012 to 2024. All the events are device recalls.

See the 30 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

30 events, newest first.

FDA enforcement events of Draeger Medical, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
15 Oct 2024	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.	Device	Class I	2	Ongoing
15 Oct 2024	Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable	Device	Class I	2	Ongoing
20 Mar 2024	Drger Perseus A500 Anesthesia Workstation	Device	Class I	1	Ongoing
12 Jul 2023	Carina Sub-Acute Care Ventilator	Device	Class I	1	Ongoing
12 Jun 2023	Oxylog 3000 Plus emergency and transport ventilator	Device	Class I	1	Ongoing
17 Apr 2023	Seattle PAP Plus, MP02260	Device	Class I	22	Terminated
23 Jan 2023	NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)	Device	Class I	2	Ongoing
16 May 2022	Drager SafeStar 55, Catalog No. MP01790	Device	Class I	1	Ongoing
14 Feb 2022	Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400	Device	Class II	2	Terminated
16 Dec 2021	Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300	Device	Class II	1	Terminated
10 Sep 2021	Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400	Device	Class II	2	Ongoing
16 Apr 2021	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.	Device	Class II	4	Terminated
29 Jan 2021	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. Intended for single use only.	Device	Class II	4	Terminated
21 Dec 2018	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 with Water trap: Breathing circuit for…	Device	Class I	9	Terminated
24 May 2018	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. Fabius series machines are equipped with a…	Device	Class II	5	Terminated
26 Apr 2018	Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.	Device	Class II	1	Terminated
1 Mar 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 by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia…	Device	Class I	4	Terminated
22 Jun 2016	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 and infants with a body weight of up to 8…	Device	Class II	1	Terminated
31 May 2016	Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.	Device	Class I	1	Terminated
21 Apr 2016	Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer	Device	Class II	1	Terminated
4 Feb 2016	Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.	Device	Class I	1	Terminated
22 Dec 2015	Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.	Device	Class I	2	Terminated
1 Dec 2015	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.	Device	Class I	1	Terminated
12 Nov 2015	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.	Device	Class I	1	Terminated
13 Jul 2015	PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.	Device	Class I	1	Terminated
22 Jun 2015	Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.	Device	Class II	1	Terminated
25 Mar 2014	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 medical gases to a patient during…	Device	Class II	1	Terminated
30 Sep 2013	Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care	Device	Class II	1	Terminated
14 Aug 2013	Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.	Device	Class I	1	Terminated
13 Dec 2012	Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Draeger Medical, Inc.: events for each product type
Type		Events
Device		30

Draeger Medical, Inc.: events in each class
Class		Events
Class I		17
Class II		13

Share of the events of the firm in Class I: 57%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 8

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Draeger Medical, Inc., by the year that the recall started. The largest year is 2015, with 5 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Draeger Medical, Inc.: FDA recalls. https://recallregister.com/firm/draeger-medical-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: PA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Draeger Medical, Inc. have?: Class I: 17 events. Class II: 13 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Draeger Medical, Inc.?: FDA event 95759, which the firm started on 15 Oct 2024. The first product in the record is: 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.
How many FDA recalls of Draeger Medical, Inc. have the status Ongoing?: 8 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.