Class II — Breas Medical, Inc.
| Recalling firm | BREAS MEDICAL, INC. |
|---|---|
| Registered facility | BREAS MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 |
| Quantity | 707 units |
| Distribution | US Nationwide |
| Initiated | 2022-03-21 |
| Classified | 2022-04-14 |
| Terminated | 2024-12-13 |
| Recall number | Z-0943-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Breas Medical, Inc. (Z-0943-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89776/
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