Class I — Draeger Medical, Inc.
| Recalling firm | Draeger Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Product | Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. |
| Quantity | 280 units (OUS only) |
| Distribution | No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, … |
| Initiated | 2024-10-15 |
| Classified | 2024-12-18 |
| Recall number | Z-0667-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Draeger Medical, Inc. (Z-0667-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95759/
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