---
title: "Breas: Vivo 45 LS (US Version) Ventilator — FDA announcement Aug 9, 2024 | Is It on Recall"
description: "Potential for short term elevated levels of formaldehyde exposure"
url: https://isitonrecall.com/recall/fdapress-a088db4e7304407c-breas-vivo-45-ls-us-version-ventilator/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Breas: Vivo 45 LS (US Version) Ventilator — FDA announcement Aug 9, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Vivo 45 LS (US Version) Ventilator
- **Reason**: Potential for short term elevated levels of formaldehyde exposure
- **Classification**: Not supplied
- **Recalling firm**: Breas Medical
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: a088db4e7304407c

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/breas-medical-issues-voluntary-us-nationwide-urgent-medical-device-correction-in-vivo-45-ls-ventilator)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Affected Product Information Table; Model name \| Model number \| UDI-DI \| D\*\*\*\*\*, F\*\*\*\*\*, K\*\*\*\*\*, M\*\*\*\*\*, N01\*\*\* - N270030 Manufacturing dates up to and including “240530” (May 30th, 2024) |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| Column 1 | Column 2 | Column 3 | Column 4 |
| --- | --- | --- | --- |
| Affected Product Information Table | Affected Product Information Table | Affected Product Information Table | Affected Product Information Table |
| Model name | Model number | UDI-DI | D\*\*\*\*\*, F\*\*\*\*\*, K\*\*\*\*\*, M\*\*\*\*\*, N01\*\*\* - N270030 Manufacturing dates up to and including “240530” (May 30th, 2024) |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/breas-medical-issues-voluntary-us-nationwide-urgent-medical-device-correction-in-vivo-45-ls-ventilator).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Aug 9, 2024
- **Company announcement date**: Aug 9, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Patients, caregivers and other users of the Vivo 45 LS device with questions may contact the Breas Medical via telephone at 1-855-436-8724 Monday through Friday between the hours of 8.00 am and 5.00 pm (Eastern time zone). You may also contact the company via e-mail at vivotechnicalsupport@breas.com

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/breas-medical-issues-voluntary-us-nationwide-urgent-medical-device-correction-in-vivo-45-ls-ventilator)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Breas Medical records](https://isitonrecall.com/brand/breas-medical/)