Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Protective Cover Vivo 55/65 (Used for Vivo 50/65) Recalled by Breas Medical, Inc. Due to The outlet hole of the exhalation valve control...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Breas Medical, Inc. directly.
Affected Products
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.
Quantity: 629
Why Was This Recalled?
The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Breas Medical, Inc.
Breas Medical, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report