FDAMay 7, 2026device
Atlan A350. Model Number: 8211500. anesthesia workstation
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
What to do
FDA enforcement status: Ongoing
Brands named
draeger
UPCs
04048675556176
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAtlan A350XL. Model Number: 8621600. anesthesia workstation2026-05-07
- FDADraeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.2025-11-24
- FDADraeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.2025-11-24
- FDAErgoStar 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.2025-11-10
- FDAErgoStar 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.2025-11-10
- FDAErgoStar 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.2025-11-10
- FDAErgoStar 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.2025-11-10
- FDABrand 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 venti...2025-09-09
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