Class I — Draeger, Inc.
| Recalling firm | Draeger, Inc. |
|---|---|
| Registered facility | DRAEGER, INC. (the firm's only registered 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 | Atlan A350XL. Model Number: 8621600. anesthesia workstation |
| Quantity | 394 units |
| Distribution | US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia… |
| Initiated | 2026-05-07 |
| Classified | 2026-06-04 |
| Recall number | Z-2208-2026 |
| 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, Inc. (Z-2208-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98914/
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