CLASS II Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

Breas Ventilator Trolley with the Vivo 50/60/65 recalled

Breas Medical is recalling Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator, distributed nationwide in the US. The recall was initiated on 21 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTrolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849

Quantity recalled707 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-0943-2022
FDA event ID: 89776
Recalling firm: Breas Medical, North Billerica, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2022
FDA classified: 14 Apr 2022
Reported: 20 Apr 2022
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

21 Mar 2022	Recall initiated by company
14 Apr 2022	Classified by FDA	+24 days
20 Apr 2022	Published in enforcement report	+6 days

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

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

Product as listed by the FDA

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

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide

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
6 Dec 2023Device	CLASS II	with Notch 22M/15F sold as part of Breas Medical MPV recalled	Breas Medical	Other	Nationwide
20 Jul 2022Device	CLASS II	Vivo 45LS Ventilator- intended to provide continuous recalled	Breas Medical	Device Malfunction	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