CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report

with Notch 22M/15F sold as part of Breas Medical MPV recalled

Breas Medical is recalling with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, distributed nationwide in the US. The recall was initiated on 13 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled215 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0405-2024
FDA event ID: 93331
Recalling firm: Breas Medical, North Billerica, MA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Oct 2023
FDA classified: 27 Nov 2023
Reported: 6 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

13 Oct 2023	Recall initiated by company
27 Nov 2023	Classified by FDA	+45 days
6 Dec 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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.

Where it was distributed

Nationwide Foreign: Canada

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Foreign: Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Breas Medical

All 5

Reported	Class	Recall	Company	Reason	Where
11 Sep 2024Device	CLASS I	Vivo 45 LS, pressure and volume ventilator capable recalled	Breas Medical	Other	Nationwide
20 Jul 2022Device	CLASS II	Vivo 45LS Ventilator- intended to provide continuous recalled	Breas Medical	Device Malfunction	Nationwide
20 Apr 2022Device	CLASS II	Breas Ventilator Trolley with the Vivo 50/60/65 recalled	Breas Medical	Other	Nationwide
4 Mar 2020Device	CLASS II	Protective Cover Vivo 55/65 (Used for Vivo 50/65) recalled	Breas Medical	Other	Nationwide

Other CPAP & Ventilators recalls

All 552

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide