Draeger Medical, Inc.
Country not established
- Devices
- 92
- FDA recalls
- 10312 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Draeger Medical, Inc. makes
Draeger Medical, Inc. manufactures anesthesia delivery systems, including the NARKOMED MRI and NARKOMED 6000 anesthesia machines, as well as respiratory gas analyzers like the SPECTRAMED. Their portfolio also includes vaporizers (e.g., VAPOR 19, DRAGER-VAPOR 2000), anesthesia recorders, pressure monitors with self-diagnostic features, and scavenging components such as the NAD Scavenging Relief Valve. Pediatric-specific devices, like the PEDIATRIC BELLOWS, are also part of their offerings.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via 510(k) clearances. Products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 92 devicesShowing 1-50 of 92
FDA recalls
FDA recall records list 103 recalls initiated by Draeger Medical, Inc., the earliest on 2003-05-07 and the most recent on 2024-10-15. By recorded status: 12 ongoing and 91 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 19
- 2019 0
- 2020 0
- 2021 11
- 2022 3
- 2023 26
- 2024 5
- 2025 0
- 2026 0
2024
- 15 Oct 2024 Z-0304-2025 Class I Ongoing The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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- 15 Oct 2024 Z-0305-2025 Class I Ongoing The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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- 15 Oct 2024 Z-0667-2025 Class I Ongoing The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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- 15 Oct 2024 Z-0668-2025 Class I Ongoing The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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- 20 Mar 2024 Z-1512-2024 Class I Ongoing Unexpected shutdown while operating on battery power.
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- 15 Oct 2024 Z-0304-2025 Class I Ongoing The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2023
- 12 Jul 2023 Z-2248-2023 Class I Ongoing Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
- 12 Jun 2023 Z-2018-2023 Class I Ongoing Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
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- 17 Apr 2023 Z-1439-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1440-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1441-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Show the 25 most recent of 103 recalls
2023
- 17 Apr 2023 Z-1442-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1443-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1444-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1445-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1446-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1447-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1448-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1449-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1450-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1451-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1452-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1453-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1454-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1455-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- 17 Apr 2023 Z-1456-2023 Class I Terminated Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Frequently asked questions
How many devices does Draeger Medical, Inc. have in the registry?
The registry currently lists 92 devices for Draeger Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Draeger Medical, Inc.'s devices?
Among its 50 most recently registered devices, Draeger Medical, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Draeger Medical, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Draeger Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Draeger Medical, Inc.?
FDA recall records list 103 recalls initiated by Draeger Medical, Inc., the most recent initiated on 2024-10-15. 12 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Draeger Medical, Inc. in the registry?
The most recently registered devices listed for Draeger Medical, Inc. include NARKOMED MRI ANESTHESIA SYSTEM, SPECTRAMED RESPIRATORY GAS ANALYZER, EVITE XL and VAPOR 19.