DreamStation Auto BiPAP — Class I medical device recall Z-2228-2025
Ongoing recall by Philips Respironics, Inc., reported 2025-08-20, distributed nationwide. Devices may possess a programming error resulting in an incorrect device configuration.
| Recall number | Z-2228-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2025-06-30 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 00606959429772 |
| Serial numbers | J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77 |
| Model numbers | UDSX700S11F |
Product
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Reason for recall
Devices may possess a programming error resulting in an incorrect device configuration.
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-2228-2025. 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.