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.
Other recalls by Devilbiss Healthcare
- DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA Device · Class II · 2023-05-10 · Devilbiss Healthcare - 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen
FDA Device · Class II · 2022-11-23 · Devilbiss Healthcare - DeVilbiss Model 7305P-D Powered Suction Unit
FDA Device · Class II · 2016-07-27 · Devilbiss Healthcare - DeVilbiss Model DV5x Series CPAP units
FDA Device · Class III · 2014-07-09 · Devilbiss Healthcare - DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6'…
FDA Device · Class II · 2013-10-09 · Devilbiss Healthcare
All Devilbiss Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0724-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.