FDA Medical Device Recalls (openFDA)
Breas Medical, Inc.: 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.
- Recall number
- Z-0405-2024
- Recalling firm
- Breas Medical, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2023-10-13
- Posted
- 2023-11-27
- Terminated
- not on file
- Reason
- 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
- Root cause
- Process control
- Action
- Breas Medical contacted customers via telephone followed by email on 10/13/23. Letter (Breas reference: SCAR-330) states reason for recall, health risk and action to take: Breas Medical recommends that all those potentially affected by this notice inspect existing inventory and identify mouthpieces which have been set up with the Vivo 45 LS for patient use. All defective mouthpieces shall be discarded. Breas Medical will provide replacement NIV Angled Mouthpieces, article number 008234, for all defective inventory and for devices in patient possession, where applicable. To obtain replacement NIV Angled Mouthpieces, we are asking customers to identify mouthpieces delivered from Breas since April 4, 2023 and complete the response form. We kindly ask you to acknowledge receipt of this Field Safety Notice together with your choice to remedy the issue using attached reply form NIV Angled Mouthpiece Field Safety Notice Distributor/Customer Reply Form. Contact Information Email: fsn@breas.com Helpline: +1 (855) 436-8724 Postal Address 16 Esquire Road, N. Billerica, MA 01862 Web Portal: breas.com
- Quantity
- 215 units
- Distribution
- Nationwide Foreign: Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K193586","K233452"]
- PMA numbers
- not on file
- Product code
- NOU
- Firm FEI
- 3010817335
- Firm city
- North Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28