Draeger, Inc. recall records

21 reported ongoing

21 records in this archive. Latest source date May 7, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Atlan A350. Model Number: 8211500. anesthesia workstation

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Class IReported ongoing

Distribution: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgiu...

Official source for Atlan A350. Model Number: 8211500. anesthesia workstation
FDA device enforcement

Atlan A350XL. Model Number: 8621600. anesthesia workstation

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Class IReported ongoing

Distribution: US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgiu...

Official source for Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA device enforcement

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube...

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Class IReported ongoing

Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ec...

Official source for ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases...
FDA device enforcement

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tu...

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Class IReported ongoing

Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ec...

Official source for ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gas...
FDA device enforcement

ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tu...

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Class IReported ongoing

Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ec...

Official source for ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gas...
FDA device enforcement

ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tu...

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

Class IReported ongoing

Distribution: Worldwide distribution. US states of CA, FL, IL, NY, OH, OK, PA, SC, TX, and WI; Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Ec...

Official source for ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gas...
FDA device enforcement

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended fo...

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Class IReported ongoing

Distribution: Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, P...

Official source for Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not ap...
FDA device enforcement

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended ...

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Class IReported ongoing

Distribution: Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, P...

Official source for Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not ...
FDA device enforcement

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA...

Official source for SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
FDA device enforcement

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA...

Official source for SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
FDA device enforcement

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA...

Official source for HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
FDA device enforcement

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA...

Official source for SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
FDA device enforcement

Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathin...

The potential for cracks forming in the breathing circuit hose.

Class IReported ongoing

Distribution: Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hu...

Official source for Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Versi...
FDA device enforcement

Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying brea...

The potential for cracks forming in the breathing circuit hose.

Class IReported ongoing

Distribution: Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hu...

Official source for Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software V...
FDA device enforcement

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for ...

The potential for cracks forming in the breathing circuit hose.

Class IReported ongoing

Distribution: Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hu...

Official source for Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Numb...
FDA device enforcement

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for ...

The potential for cracks forming in the breathing circuit hose.

Class IReported ongoing

Distribution: Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hu...

Official source for Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Numb...
FDA device enforcement

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for ...

The potential for cracks forming in the breathing circuit hose.

Class IReported ongoing

Distribution: Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hu...

Official source for Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Numb...
FDA device enforcement

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory f...

The potential for cracks forming in the breathing circuit hose.

Class IReported ongoing

Distribution: Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hu...

Official source for Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog N...

Reasons in these listed records

  • The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
  • A certain component of affected devices was not delivered within specification and contained impurities.
  • Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
  • The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

These examples come from this result page and are not a ranking of every recall reason.

Checking Draeger, Inc.

Is there a recall on draeger, inc. right now?

This archive contains 21 records, including 21 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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