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 A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable |
| Quantity | 1,492 units (139 units US, 1,353 OUS) |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland… |
| Initiated | 2024-10-15 |
| Classified | 2024-11-13 |
| Recall number | Z-0304-2025 |
| 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-0304-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95561/
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