BiPAP V30 Auto Ventilator — Class I medical device recall Z-2035-2025
Ongoing recall by Philips Respironics, Inc., reported 2025-07-09, distributed nationwide. This device does not indicate for use in patients with respiratory failure.
| Recall number | Z-2035-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2025-05-09 |
| Classified | 2025-07-02 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CL, CN, CO, CR, DE, DK, ES, FR, GB, HK, HU, ID, IE, IN, IT, JO, JP, KR, LB, MA, MX, MY, NL, NO, NP, PE, PH, PK, PL, PT, QA, RO, RS, SG, SK, TH, TR, TW, VN, ZA |
| Quantity | 5,958 units |
| UPC / GTIN / UDI-DI | 00060959049635, 00206864878339, 00212492192136, 00213532372839, 00214372232260, 00214482192577, 00214494554219, 00214811592320, 00215416047963, 00216765973514, 00216768340580, 00216768455901, 00219184839867, 00219428310084, 00219428463933, 00220345047465, 00222265958890, 00222266068277, 00222267280265, 00222267548501, 00225594618954, 00226593530056, 00227721760345, 00229768729231, 00231653891688 and 75 more |
| Serial numbers | N205345571B7A, N20534558E38D, N20534559F204, N2053456045AD, N205345615424, N2053456266BF, N205345637736, N205345640389, N205345651200, N20534566209B, N205345673112, N20534568C9E5, N20534569D86C, N205345705C75, N205345714DFC, N205345727F67, N205345736EEE, N205345741A51, N205345750BD8, N2068642229E4, N206864244CD2, N206864255D5B, N206864266FC0, N206864277E49, N2068642886BE and 475 more |
| Model numbers | 1111178 |
Product
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Reason for recall
This device does not indicate for use in patients with respiratory failure.
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-2035-2025. 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.