BiPAP A30 Ventilators — Class I medical device recall Z-2036-2025
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-2036-2025 |
|---|---|
| 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 |
| UPC / GTIN / UDI-DI | 00071484979335, 00090582134446, 00100866312535, 00100867632243, 00100868101717, 00100868123405, 00101173411874, 00101173501025, 00101605387999, 00101605492518, 00102715708933, 00103073125745, 00103081362590, 00103081477911, 00103081545252, 00103907230980, 00103908446328, 00103911780389, 00106383900125, 00108782579254, 00110817569772, 00112497461414, 00113841175568, 00115802309715, 00115810662598 and 323 more |
| Serial numbers | L2143745010D0, L2143750217A6, L218353956A5A, L218354125C20, L218354134DA9, L218354161A04, L21835428D912, L21835429C89B, L218354411003, L21835487DC95, L2183549292E0, L218355021F24, L21942942BE31, L21942955D356, L22559557072C, L22559558FFDB, L22559559EE52, L2255956059FB, L225595627AE9, L225595636B60, L225595641FDF, L225595663CCD, L2297692882F5, L229769389B2D, L229769414BE4 and 475 more |
| Model numbers | 1076540, 1076581, 1076582, 1076583, 1101109, 1109594, 1111143, 1111144, 1111144L, 1111144M, 1111144V, 1111145, 1111147, 1111148, 1111149, 1111150, 1111154, 1111181, 1116155, BR1111143, CN1111143, R1076491, R1111143 |
Product
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
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-2036-2025. 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.