Food, drugs, devices › Draeger Medical, Inc.

Device recall: Oxylog 3000 Plus emergency and transport ventilator

FDA enforcement event 92443 · Class I · initiated 12 Jun 2023 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordTelford, PA

FDA enforcement event 92443 is a device recall by Draeger Medical, Inc. of Telford, PA, initiated 12 Jun 2023 and classified Class I, with 1 product record.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 10% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Draeger Medical, Inc. has 30 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, Inc., Telford, PA.

Reason for recall

"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,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2018-2023	Oxylog 3000 Plus emergency and transport ventilator	300 units	Class I	Ongoing	19 Jul 2023

Context

10%of 2023 device events are Class I917 events that year

1product record in this eventfirm median: 1

30events on this register for the firm

Other enforcement events for Draeger Medical, Inc.

Initiated	Product (first record)	Type	Class	Records
15 Oct 2024	Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended	Device	Class I	2
15 Oct 2024	Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not	Device	Class I	2
20 Mar 2024	Dr¿ger Perseus A500 Anesthesia Workstation	Device	Class I	1
12 Jul 2023	Carina Sub-Acute Care Ventilator	Device	Class I	1
17 Apr 2023	Seattle PAP Plus, MP02260	Device	Class I	22
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
16 May 2022	Drager SafeStar 55, Catalog No. MP01790	Device	Class I	1
14 Feb 2022	Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal pa	Device	Class II	2
16 Dec 2021	Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300	Device	Class II	1
10 Sep 2021	Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal	Device	Class II	2

All 30 events for Draeger Medical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra, Angola, Antigua/Barbados, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bolivia, Brunei Dar-es-S,…"

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.