DreamStation Auto CPAP — Class I medical device recall Z-2227-2025
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-2227-2025 |
|---|---|
| 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 | 57 units |
| UPC / GTIN / UDI-DI | 00207023218478, 00301116505688, 00606959429765 |
| Serial numbers | J204432084D03, J206957368810, J207023218478, J21450857096A, J219786492F58, J222909239F3E, J22718022B9D6, J22924665CF8A, J230303131D07, J23148826984B, J23307132CC16, J2379520271A4, J23933071851F, J23963189F617, J242941498857, J243763392C02, J24551698A015, J247575014664, J24858283A8C3, J24994323EB40, J2529261301FF, J2543728920D9, J254401628C83, J25467463E51E, J25493556DA17 and 32 more |
| Model numbers | UDSX500S11F |
Product
DreamStation Auto CPAP. 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-2227-2025. 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.