FDASeptember 9, 2025device
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 venti...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device 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 A350. Model Number: 8211500. anesthesia workstation2026-05-07
- FDAAtlan A350XL. Model Number: 8621600. anesthesia workstation2026-05-07
- FDADraeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.2025-11-24
- FDADraeger Vapor 3000. 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 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 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 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
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