Draeger, Inc. Recalls

19 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (19)

November 24, 2025
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
Class I
November 24, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
A certain component of affected devices was not delivered within specification and contained impurities.
Class I
November 10, 2025
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 m
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I
November 10, 2025
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 me
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I
November 10, 2025
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 m
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I
November 10, 2025
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 mecha
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
Class I
September 9, 2025
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 anesthet
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class I
September 9, 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 anesthetiz
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class I
June 16, 2025
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 I
June 16, 2025
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 I
June 16, 2025
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 I
June 16, 2025
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 I
March 12, 2025
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 medic
The potential for cracks forming in the breathing circuit hose.
Class I
March 12, 2025
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
The potential for cracks forming in the breathing circuit hose.
Class I
March 12, 2025
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
The potential for cracks forming in the breathing circuit hose.
Class I
March 12, 2025
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
The potential for cracks forming in the breathing circuit hose.
Class I
March 12, 2025
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
The potential for cracks forming in the breathing circuit hose.
Class I
March 12, 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
The potential for cracks forming in the breathing circuit hose.
Class I
March 12, 2025
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 medica
The potential for cracks forming in the breathing circuit hose.
Class I

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.