Breas Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0943-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Product Classification:

Class II

Date Initiated: March 21, 2022

Date Posted: April 20, 2022

Recall Number: Z-0943-2022

Event ID: 89776

Reason for Recall:

Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

Status: Terminated

Product Quantity: 707 units

Code Information:

Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated