Vivo 45 LS — Class I medical device recall Z-2690-2024
Ongoing recall by Breas Medical, Inc., reported 2024-09-11, distributed nationwide. There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the
| Recall number | Z-2690-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breas Medical, Inc., North Billerica, MA, United States |
| Recall initiated | 2024-07-25 |
| Classified | 2024-09-03 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 8,298 |
| UPC / GTIN / UDI-DI | 07321822300004 |
| Lot numbers | 240530 |
| Model numbers | 230000 |
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)
Reason for recall
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.
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-2690-2024. 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.