Device recall: Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and…

Class I FDA enforcement event 66025. Recall start date: 14 Aug 2013. Status in the FDA record: Terminated. Termination date: 23 Sep 2014.

Reason for recall, in the words of FDA

During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

Class I, in the words of FDA

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

Draeger Medical, Inc. started this device recall on 14 Aug 2013. The firm address in the FDA record is in Telford, PA. FDA put the recall in Class I. FDA event 66025 has 1 product record. The first FDA enforcement report date is 16 Oct 2013. The record gives the status Terminated, with the termination date 23 Sep 2014.

FDA enforcement report The 1 product record

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.

Distribution

In the words of FDA.

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany,…

Recalling firm

Draeger Medical, Inc., Telford, PA.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 66025: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0008-2014	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.	1127 units	Class I	Terminated	16 Oct 2013

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class I: 6%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of 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	Drger Perseus A500 Anesthesia Workstation	Device	Class I	1
12 Jul 2023	Carina Sub-Acute Care Ventilator	Device	Class I	1
12 Jun 2023	Oxylog 3000 Plus emergency and transport 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

Draeger Medical, Inc.: all 30 events

Official channels

FDA enforcement report Z-0008-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 66025. https://recallregister.com/fda/i/66025/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany,…
What quantity of product is in FDA event 66025?: The FDA record gives this quantity: 1127 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 6% of the 1,236 device events that started in 2013 are in Class I.