Draeger Medical Systems, Inc.: FDA recalls

FDA enforcement reports name Draeger Medical Systems, Inc. as the recalling firm in 10 events. The events have 12 product records. The recalls started from 2012 to 2025. All the events are device recalls.

See the 10 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

10 events, newest first.

FDA enforcement events of Draeger Medical Systems, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
14 Jan 2025	Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors…	Device	Class II	1	Ongoing
13 May 2024	Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23	Device	Class II	1	Ongoing
16 May 2023	Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]	Device	Class II	1	Ongoing
5 Apr 2023	Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower	Device	Class II	2	Ongoing
20 May 2022	Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system	Device	Class II	1	Ongoing
15 May 2018	Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with…	Device	Class I	2	Terminated
5 Mar 2014	Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833	Device	Class I	1	Terminated
7 Feb 2014	Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.	Device	Class I	1	Terminated
10 Dec 2013	Draeger Infinity Acute Care System Monitoring Solution	Device	Class II	1	Terminated
2 Jul 2012	Drager PT 4000 Phototherapy 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 Systems, Inc.: events for each product type
Type		Events
Device		10

Draeger Medical Systems, Inc.: events in each class
Class		Events
Class II		7
Class I		3

Share of the events of the firm in Class I: 30%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 5

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 Systems, Inc., by the year that the recall started. The largest year is 2014, with 2 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 Systems, Inc.: FDA recalls. https://recallregister.com/firm/draeger-medical-systems-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, MA

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 Systems, Inc. have?: Class II: 7 events. Class I: 3 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 Systems, Inc.?: FDA event 96057, which the firm started on 14 Jan 2025. The first product in the record is: Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors…
How many FDA recalls of Draeger Medical Systems, Inc. have the status Ongoing?: 5 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.