bellavista 1000 ventilator — Class I medical device recall Z-0622-2022
Terminated recall by Vyaire Medical, reported 2022-02-23, distributed nationwide. Potential cessation in ventilation can occur under specific conditions.
| Recall number | Z-0622-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2021-12-20 |
| Classified | 2022-02-16 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EG, ES, FR, GB, GT, ID, IL, IN, IR, IT, JO, JP, KE, KR, KW, LT, LV, MX, MY, NI, NL, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SV, TH, TR, VN, ZA |
| Quantity | 4,189 units |
| UPC / GTIN / UDI-DI | 07640149381115, 07640149388879 |
| Serial numbers | 07640149381115, 07640149388879, 1000, 1000E |
| Model numbers | 301.100.030 |
Product
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
Reason for recall
Potential cessation in ventilation can occur under specific conditions.
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-0622-2022. 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.