# FDA recall Z-2690-2024

> **Breas Medical, Inc.** · Class I · device recall initiated 2024-07-25.

## 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.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-2690-2024
- **Recalling firm:** Breas Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-25
- **Report date:** 2024-09-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2690-2024

## Citation

> AI Analytics. FDA recall Z-2690-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2690-2024. Source: US FDA. Licensed CC0.

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