Class I — Breas Medical, Inc.
| Recalling firm | BREAS MEDICAL, INC. |
|---|---|
| Registered facility | BREAS MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. |
| Product | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216) |
| Quantity | 8298 |
| Distribution | US Nationwide. |
| Initiated | 2024-07-25 |
| Classified | 2024-09-03 |
| Recall number | Z-2690-2024 |
| 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 I recall — Breas Medical, Inc. (Z-2690-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95042/
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