# FDA recall Z-0405-2024

> **Breas Medical, Inc.** · Class II · device recall initiated 2023-10-13.

## Product

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.

## 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

## Distribution

Nationwide Foreign: Canada

## Key facts

- **Recall number:** Z-0405-2024
- **Recalling firm:** Breas Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-13
- **Report date:** 2023-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0405-2024

## Citation

> AI Analytics. FDA recall Z-0405-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0405-2024. Source: US FDA. Licensed CC0.

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