Class II — DeVilbiss Healthcare LLC
| Recalling firm | Drive DeVilbiss Healthcare |
|---|---|
| Registered facility | DeVilbiss Healthcare LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. |
| Product | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR |
| Quantity | 143,397 units |
| Distribution | Worldwide - US Nationwide distribution. |
| Initiated | 2023-03-09 |
| Classified | 2023-05-04 |
| Recall number | Z-1558-2023 |
| 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 II recall — DeVilbiss Healthcare LLC (Z-1558-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91804/
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