Food, drugs, devices › Draeger Medical Systems, Inc.

Device recall: Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

FDA enforcement event 90423 · Class II · initiated 20 May 2022 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordTelford, PA

FDA enforcement event 90423 is a device recall by Draeger Medical Systems, Inc. of Telford, PA, initiated 20 May 2022 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Draeger Medical Systems, Inc. has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Draeger Medical Systems, Inc., Telford, PA.

Reason for recall

"The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system."

Distribution

"No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1365-2022	Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system	38 OUS (no US distribution)	Class II	Ongoing	20 Jul 2022

Context

88%of 2022 device events are Class II839 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Draeger Medical Systems, Inc.

Initiated	Product (first record)	Type	Class	Records
14 Jan 2025	Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring	Device	Class II	1
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
16 May 2023	Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1	Device	Class II	1
5 Apr 2023	Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the h	Device	Class II	2
15 May 2018	Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician	Device	Class I	2
5 Mar 2014	Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833	Device	Class I	1
7 Feb 2014	Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or	Device	Class I	1
10 Dec 2013	Draeger Infinity Acute Care System Monitoring Solution	Device	Class II	1
2 Jul 2012	Drager PT 4000 Phototherapy System	Device	Class II	1

All 10 events for Draeger Medical Systems, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.