BiPAP A40 — Class II medical device recall Z-1626-2021
Terminated recall by Philips Respironics, Inc., reported 2021-06-02, distributed nationwide. Certain devices were built with motor assemblies that could contain non-conforming plastic material. This coul
| Recall number | Z-1626-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2021-04-06 |
| Classified | 2021-05-21 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2024-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CN, JP |
| Quantity | 10 units |
| UPC / GTIN / UDI-DI | 00304441360854 |
| Serial numbers | V30444034719A, V304441360854, V304441766F34, V3044555732D7, V304457587F98, V3044642346EA, V30446637ACAE, V30446653BE5A, V304468408502, V30446846E034 |
Product
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Reason for recall
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
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-1626-2021. 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.