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# Breas Medical Recalls Vivo 45 LS Ventilators
- URL: https://www.fdaweb.com/breas-medical-recalls-vivo-45-ls-ventilators/
- Published: 2024-09-05T12:00:00.000Z
- Updated: 2026-09-14T14:40:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157718

Breas Medical is recalling (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing of the devices identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time. “The use of affected product and short-term exposure to formaldehyde emissions may cause serious adverse health consequences, especially in small pediatric patients, that include temporary, reversible airway irritation or inflammation leading to airway issues such as asthma, and death,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/ventilator-correction-breas-medical-updates-use-instructions-in-vivo-45-ls-due-potential-elevated?ref=fdaweb.com) says. To date, there have been no reported injuries or deaths.

The ventilator is intended to provide continuous or intermittent ventilatory support for people who require mechanical ventilation to support their breathing. The devices are used in adults and pediatric patients weighing more than 5kg in home and healthcare settings, as well as portable ventilators for wheelchairs and gurneys.