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Breas Medical, Inc.: Medical Device Recalls in 2020

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Breas Medical, Inc. in 2020. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.
See this for other years:
2020
2022
2023
2024
  • Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.
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