Breas Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0405-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

Product Classification:

Class II

Date Initiated: October 13, 2023

Date Posted: December 6, 2023

Recall Number: Z-0405-2024

Event ID: 93331

Reason for Recall:

Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation

Status: Ongoing

Product Quantity: 215 units

Code Information:

UDI-DI: 05030267120505 NIV Angled Mouthpiece with Notch 22M/15F; 07321820060931 MPV Kit 006093; 07321820066537 MPV Kit 006653 MPV mouthpiece Lot Numbers: 32304444, 32305269 and 32306017

Distribution Pattern:

Nationwide Foreign: Canada

Voluntary or Mandated:

Voluntary: Firm initiated