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 firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components. |
| Product | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q |
| Quantity | 1004315 (US); 414559 (OUS) |
| Distribution | US Nationwide. Foreign distribution pending. |
| Initiated | 2022-11-18 |
| Classified | 2022-12-19 |
| Recall number | Z-0724-2023 |
| 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-0724-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91112/
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