FDA Device recall Z-0724-2023
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q by Devilbiss Healthcare, citing 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 si….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0724-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-18 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Devilbiss Healthcare |
| Distribution | US |
Product
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
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.
Identifiers
| code_info | Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0724-2023%22
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