DeVilbiss — Class II medical device recall Z-0724-2023
Ongoing recall by DeVilbiss Healthcare LLC, reported 2022-12-28, distributed nationwide. The firm has received complaints of the device becoming hot. The firm has updated the user manual to include w
| Recall number | Z-0724-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeVilbiss Healthcare LLC, Somerset, PA, United States |
| Recall initiated | 2022-11-18 |
| Classified | 2022-12-19 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00885304000846, 00885304009689 |
| Model numbers | 525DS, 525DS-Q |
Product
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0724-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.