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Draeger Medical, Inc.

Also registered as Draeger Medical AG & Co. KG, Draeger Medical GmbH

Country not established

Devices
92
FDA recalls
10312 ongoing

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue92

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FDA recalls103

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

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.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 19
  • 2019 0
  • 2020 0
  • 2021 11
  • 2022 3
  • 2023 26
  • 2024 5
  • 2025 0
  • 2026 0

39 initiated before 2017

Showing the 10 most recent of 103 recalls.

  • 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. Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX,…
      Full distribution text US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
      Submission number: K230931
    • 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. Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX,…
      Full distribution text US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
      Submission number: K230931
    • 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. Distribution: No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA…
      Full distribution text No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.
      Submission number: K230931
    • 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. Distribution: No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA…
      Full distribution text No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.
      Submission number: K230931
    • 20 Mar 2024 Z-1512-2024 Class I Ongoing Unexpected shutdown while operating on battery power. Distribution: Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia,…
      Full distribution text Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-se- S, Bulgaria, Canada, Chili, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, French Guiana, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Maldives, Mauritius, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
      Submission number: K133886

  • 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. Distribution: US Nationwide Distribution. Submission number: K072885
    • 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. Distribution: Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra, Angola, Antigua/Barbados, Argentina, Australia,…
      Full distribution text Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra, Angola, Antigua/Barbados, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bolivia, Brunei Dar-es-S, Bulgaria, Burkina-Faso, Cambodia, Canada, Cayman Islands, Chile, China, Christmas Island, Columbia, Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Faeroe, Finland, France, French Polynesia, French Guiana, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Macau, Malawi, Malaysia, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, North Korea, Norway, Oman, Pakistan, Panama,…
      Submission number: K103625
    • 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. Distribution: Domestic: US Nationwide Distribution. Submission number: K131502
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.
    • 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. Distribution: Domestic: US Nationwide Distribution.