46 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
FDA Recall
Open, Classified
·Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee·Product code BSZ·November 17, 2023
Atlan A350XL. Model Number: 8621600. anesthesia workstation
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BSZ·May 7, 2026
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 anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·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 medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·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 gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAH·June 16, 2025
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAH·June 16, 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 mechanically ventilated patient.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BZA·November 10, 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 gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 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 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 surgical or diagnostic interventions Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BSZ·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 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 surgical or diagnostic interventions Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BSZ·September 9, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAD·November 24, 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 an anesthesia machine or ventilator and adult Component: Not applicable
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BZO·March 12, 2025
Atlan A350. Model Number: 8211500. anesthesia workstation
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BSZ·May 7, 2026
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAH·June 16, 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 mechanically ventilated patient.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BZA·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 mechanically ventilated patient.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BZA·November 10, 2025
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAD·November 24, 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 mechanically ventilated patient.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code BZA·November 10, 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 gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
FDA Recall
Open, Classified
·Draeger, Inc.·Product code OFP·March 12, 2025