Draeger, Inc.
19 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Draeger, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-31FDA-DeviceClass IDraeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
- 2025-12-31FDA-DeviceClass IDraeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
- 2025-12-17FDA-DeviceClass IErgoStar 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 ventilated patient.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
- 2025-12-17FDA-DeviceClass IErgoStar 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 ventilated patient.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
- 2025-12-17FDA-DeviceClass IErgoStar 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 ventilated patient.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
- 2025-12-17FDA-DeviceClass IErgoStar 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 patient.
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
- 2025-10-08FDA-DeviceClass IBrand 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, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use durin
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- 2025-10-08FDA-DeviceClass IBrand 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, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- 2025-08-06FDA-DeviceClass ISafeStar 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.
- 2025-08-06FDA-DeviceClass IHME 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.
- 2025-08-06FDA-DeviceClass ISafeStar 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.
- 2025-08-06FDA-DeviceClass ISafeStar 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.
- 2025-04-09FDA-DeviceClass IBrand 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 anesthesia machine and patient for anesthetic use. Kit is intended for single use only
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceClass IBrand 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 anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceClass IBrand 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 anesthesia machine and patient for anesthetic use. Kit is intended for single use only
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceClass IBrand 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 anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceClass IBrand 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 anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceClass IBrand 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 machine or ventilator and adult Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
- 2025-04-09FDA-DeviceClass IBrand 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 or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable
The potential for cracks forming in the breathing circuit hose.
Get notified about new Draeger, Inc. recalls
Free weekly digest. We email when a new federal recall affects Draeger, Inc. or anything else in your household.
Get the Sunday Brief