DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR — Class II medical device recall Z-1558-2023
Ongoing recall by DeVilbiss Healthcare LLC, reported 2023-05-10, distributed nationwide. The instruction manual is being replaced with an updated version that is in alignment with labeling requiremen
| Recall number | Z-1558-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeVilbiss Healthcare LLC, Somerset, PA, United States |
| Recall initiated | 2023-03-09 |
| Classified | 2023-05-04 |
| Reported by FDA | 2023-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 143,397 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00853040224734, 00885304000846, 00885304022480 |
| Serial numbers | A175230001DS, A176060001KS, A179210001US, A216240003KS, A229210010KR, A232060432US, A232160185DS, A232220085KS |
| Model numbers | 1025DS, 1025KS, 1025KS-AR, 1025UK |
Product
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Reason for recall
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
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-1558-2023. 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.