Telford, PA, United States
Draeger, Inc. recalls
7 recalls recorded since 2018, most recently on 3 September 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)7
Terminated or completed0
Class I (FDA)7
Ongoing Class I Medical devices
- Recall started
- 3 September 2026
- Reason
- Potential cracks in the hose, which could lead to leakage or the hose falling off.
- Distribution
- US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, WV, WY, MS, SC, UT, VA, AR, and territories AS and PR. The countries of Canada, Germany, United Ki
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3252-2026
- VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Ongoing Class I Medical devices
- Recall started
- 7 May 2026
- Reason
- 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 distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, Fran
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2208-2026, Z-2207-2026
- Atlan A350XL. Model Number: 8621600. anesthesia workstation
- Atlan A350. Model Number: 8211500. anesthesia workstation
Ongoing Class I Medical devices
- Recall started
- 24 November 2025
- Reason
- A certain component of affected devices was not delivered within specification and contained impurities.
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, Indonesia, Isr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0933-2026, Z-0934-2026
- Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
- Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Ongoing Class I Medical devices
- Recall started
- 10 November 2025
- Reason
- Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
- 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, Ecuador, Finland, France, Germany, Hungary, Indonesia, Italy, Japan, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0593-2026, Z-0591-2026, Z-0590-2026, Z-0592-2026
- 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 tube mask) of a mechanically ventilat
- 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 tube mask) of a mechanically ventilate
- 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 mask) of a mechanically ventilated p
- 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 tube mask) of a mechanically ventilat
Ongoing Class I Medical devices
- Recall started
- 9 September 2025
- Reason
- The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- 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, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Aust
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2616-2025, Z-2617-2025
- Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatri
- Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediat
Ongoing Class I Medical devices
- Recall started
- 16 June 2025
- Reason
- Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- 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, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulga
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2158-2025, Z-2159-2025, Z-2161-2025, Z-2160-2025
- SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
- SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
- SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
- HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Ongoing Class I Medical devices
- Recall started
- 12 March 2025
- Reason
- The potential for cracks forming in the breathing circuit hose.
- Distribution
- Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1493-2025, Z-1495-2025, Z-1499-2025, Z-1497-2025, Z-1496-2025, Z-1498-2025, Z-1494-2025
- Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine o
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesth
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anes
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesth
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesth
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between ane
- Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machi
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.