← Every firm
Draeger, Inc. FDA Recalls
21 recalls on file across devices, 21 of them Class I and 21 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Atlan A350XL. Model Number: 8621600. anesthesia workstationClass IMay 7, 2026The Atlan anesthesia workstation either indicated a failure |
| Atlan A350. Model Number: 8211500. anesthesia workstationClass IMay 7, 2026The Atlan anesthesia workstation either indicated a failure |
| Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.Class INov 24, 2025A certain component of affected devices was not delivered wi |
| Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.Class INov 24, 2025A certain component of affected devices was not delivered wi |
| ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breaClass INov 10, 2025Multiple complaints were reported in which cracks formed in |
| ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the Class INov 10, 2025Multiple complaints were reported in which cracks formed in |
| ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the Class INov 10, 2025Multiple complaints were reported in which cracks formed in |
| ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the bClass INov 10, 2025Multiple complaints were reported in which cracks formed in |
| Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product DeClass ISep 9, 2025The device either indicated a failure of the piston ventilat |
| Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Class ISep 9, 2025The device either indicated a failure of the piston ventilat |
| SafeStar 90 Plus Filter. Bidirectionally breathing system filter.Class IJun 16, 2025Reports of slow increase of CO2-curve when gas sample is tak |
| SafeStar 60A Plus Filter. Bidirectionally breathing system filter.Class IJun 16, 2025Reports of slow increase of CO2-curve when gas sample is tak |
| HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.Class IJun 16, 2025Reports of slow increase of CO2-curve when gas sample is tak |
| SafeStar 55 Plus Filter. Bidirectionally breathing system filter.Class IJun 16, 2025Reports of slow increase of CO2-curve when gas sample is tak |
| Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 SoftwaClass IMar 12, 2025The potential for cracks forming in the breathing circuit ho |
| Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 SoftwareClass IMar 12, 2025The potential for cracks forming in the breathing circuit ho |
| Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 SoftwareClass IMar 12, 2025The potential for cracks forming in the breathing circuit ho |
| Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 SoftwareClass IMar 12, 2025The potential for cracks forming in the breathing circuit ho |
| Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicabClass IMar 12, 2025The potential for cracks forming in the breathing circuit ho |
| Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Class IMar 12, 2025The potential for cracks forming in the breathing circuit ho |
| Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 SoftwClass IMar 12, 2025The potential for cracks forming in the breathing circuit ho |