thejoe Draeger Medical, Inc.

Draeger Medical, Inc.: 78 FDA recall reports

Every medical device recall the FDA has published for Draeger Medical, Inc.. The fault, and how the agency graded it.

78Reports

53Class I

12Ongoing

2024-12-25Most recent

53 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class I	53
Class II	25

By year reported

Year	Reports
2013	3
2014	1
2015	4
2016	6
2018	10
2019	9
2021	10
2022	4
2023	26
2024	5

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Class I

Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia

Z-0668-2025 · Class I · reported 2024-12-25 · Ongoing

Why it was recalled: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Product: Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Where it went: 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.
How much: 25 units (OUS Only)

Class I

Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia wo

Z-0667-2025 · Class I · reported 2024-12-25 · Ongoing

Why it was recalled: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Product: Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Where it went: 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.
How much: 280 units (OUS only)

Class I

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable

Z-0305-2025 · Class I · reported 2024-11-20 · Ongoing

Why it was recalled: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Product: Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Where it went: 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.
How much: 455 units (310 units US, 145 OUS)

Class I

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable

Z-0304-2025 · Class I · reported 2024-11-20 · Ongoing

Why it was recalled: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Product: Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Where it went: 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.
How much: 1,492 units (139 units US, 1,353 OUS)

Class I

Dr¿ger Perseus A500 Anesthesia Workstation

Z-1512-2024 · Class I · reported 2024-04-24 · Ongoing

Why it was recalled: Unexpected shutdown while operating on battery power.
Product: Dr¿ger Perseus A500 Anesthesia Workstation
Where it went: 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.
How much: 16,841 units

Class I

Carina Sub-Acute Care Ventilator

Z-2248-2023 · Class I · reported 2023-08-30 · Ongoing

Why it was recalled: 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.
Product: Carina Sub-Acute Care Ventilator
Where it went: US Nationwide Distribution.
How much: 11,621 units

Class I

Oxylog 3000 Plus emergency and transport ventilator

Z-2018-2023 · Class I · reported 2023-07-19 · Ongoing

Why it was recalled: Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
Product: Oxylog 3000 Plus emergency and transport ventilator
Where it went: 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, Pap. New Guinea, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Rwanda, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Sint Maarten, Slovenia, Slovakia, South...
How much: 300 units

Class I

VentStar Basic (P)180, MP00351

Z-1440-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Basic (P)180, MP00351
Where it went: Domestic: US Nationwide Distribution.
How much: 325 units

Class I

Set2Go Ventilation 12 (A), MP07968

Z-1459-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Set2Go Ventilation 12 (A), MP07968
Where it went: Domestic: US Nationwide Distribution.
How much: 500 units

Class I

Seattle PAP Plus, MP02260

Z-1439-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Seattle PAP Plus, MP02260
Where it went: Domestic: US Nationwide Distribution.
How much: 32,050 untis

Class I

VentStar Anesthesia WT (P)180, MP00374

Z-1444-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Anesthesia WT (P)180, MP00374
Where it went: Domestic: US Nationwide Distribution.
How much: 130 units

Class I

Anesthesia Set Coax 180, MP03384

Z-1458-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Anesthesia Set Coax 180, MP03384
Where it went: Domestic: US Nationwide Distribution.
How much: 20 units

Class I

VentStar Watertrap (N) 180, MP00363

Z-1449-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Watertrap (N) 180, MP00363
Where it went: Domestic: US Nationwide Distribution.
How much: 125 units

Class I

VentStar Watertrap (P) 180, MP00361

Z-1442-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Watertrap (P) 180, MP00361
Where it went: Domestic: US Nationwide Distribution.
How much: 50 units

Class I

VentStar Anesthesia (N) 180, MP00333

Z-1447-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Anesthesia (N) 180, MP00333
Where it went: Domestic: US Nationwide Distribution.
How much: N/A

Class I

Ventstar Coax, MP03373

Z-1454-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Ventstar Coax, MP03373
Where it went: Domestic: US Nationwide Distribution.
How much: 2,380 units

Class I

ID Circuit Basic (P) 180, MP01340

Z-1446-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: ID Circuit Basic (P) 180, MP01340
Where it went: Domestic: US Nationwide Distribution.
How much: 25 units

Class I

VentStar Basic (P)250, MP00352

Z-1441-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Basic (P)250, MP00352
Where it went: Domestic: US Nationwide Distribution.
How much: 200 units

Class I

Anesthesia Circuit Kit Coax 3, MP02732

Z-1453-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Anesthesia Circuit Kit Coax 3, MP02732
Where it went: Domestic: US Nationwide Distribution.
How much: 329,294 units

Class I

Ventstar Coax 180, MP03374

Z-1455-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Ventstar Coax 180, MP03374
Where it went: Domestic: US Nationwide Distribution.
How much: 18,160 units

Class I

Anesthesia Circuit Kit Coax 1, MP02730

Z-1452-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Anesthesia Circuit Kit Coax 1, MP02730
Where it went: Domestic: US Nationwide Distribution.
How much: 200,900 units

Class I

VentStar Basic (N) 180, MP00353

Z-1448-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Basic (N) 180, MP00353
Where it went: Domestic: US Nationwide Distribution.
How much: 1,725 units

Class I

VentStar breathing bag Set (P) 110, MP00384

Z-1445-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar breathing bag Set (P) 110, MP00384
Where it went: Domestic: US Nationwide Distribution.
How much: 25 units

Class I

Anesthesia Circuit Kit Coax HEPA, MP17102

Z-1460-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Anesthesia Circuit Kit Coax HEPA, MP17102
Where it went: Domestic: US Nationwide Distribution.
How much: 720 units

Class I

Ventstar Coax 230, MP03376

Z-1457-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: Ventstar Coax 230, MP03376
Where it went: Domestic: US Nationwide Distribution.
How much: 40 units

Class I

VentStar Bag Set (N) 110, MP00383

Z-1450-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Bag Set (N) 110, MP00383
Where it went: Domestic: US Nationwide Distribution.
How much: 375 units

Class I

VentStar Watertrap (P) 180 w/oLL, MP00362

Z-1443-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Watertrap (P) 180 w/oLL, MP00362
Where it went: Domestic: US Nationwide Distribution.
How much: 25 units

Class I

VentStar Coax (P) 150, MP00379

Z-1451-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: VentStar Coax (P) 150, MP00379
Where it went: Domestic: US Nationwide Distribution.
How much: 280 units

Class I

ID Coax 180, MP03375

Z-1456-2023 · Class I · reported 2023-05-24 · Terminated

Why it was recalled: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Product: ID Coax 180, MP03375
Where it went: Domestic: US Nationwide Distribution.
How much: 20 units

Class I

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size

Z-1138-2023 · Class I · reported 2023-03-01 · Ongoing

Why it was recalled: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Product: NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Where it went: US Nationwide Distribution
How much: 893 units

Showing the 30 most recent of 78. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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