Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS… — Class II medical device recall Z-0943-2022
Terminated recall by Breas Medical, Inc., reported 2022-04-20, distributed nationwide. Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from th
| Recall number | Z-0943-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breas Medical, Inc., North Billerica, MA, United States |
| Recall initiated | 2022-03-21 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2024-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 707 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07321820073849 |
Product
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Reason for recall
Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity
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-0943-2022. 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.