CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

Protective Cover Vivo 55/65 (Used for Vivo 50/65) recalled

Breas Medical is recalling Protective Cover Vivo 55/65 (Used for Vivo 50/65), distributed nationwide in the US. The recall was initiated on 28 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe cover does not have a lot number; these covers were distributed between 01/11/2018 and 12/17/2019

Quantity recalled629

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-1352-2020
FDA event ID: 84828
Recalling firm: Breas Medical, North Billerica, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 Jan 2020
FDA classified: 24 Feb 2020
Reported: 4 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

28 Jan 2020	Recall initiated by company
24 Feb 2020	Classified by FDA	+27 days
4 Mar 2020	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

The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.

Product as listed by the FDA

Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AR, CA, FL, GA, IA, IL, KS, MA, MI, MO, NJ, NY, OH, PR, SC, TX, VA, WI and countries distribution worldwide.

Nationwide Arkansas California Florida Georgia Iowa Illinois Kansas Massachusetts Michigan Missouri New Jersey New York Ohio Puerto Rico South Carolina Texas Virginia Wisconsin

Questions about this recall

Why was it recalled?

The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.

Which lots are affected?

The cover does not have a lot number; these covers were distributed between 01/11/2018 and 12/17/2019

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of AR, CA, FL, GA, IA, IL, KS, MA, MI, MO, NJ, NY, OH, PR, SC, TX, VA, WI and countries distribution worldwide.

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

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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
20 Apr 2022Device	CLASS II	Breas Ventilator Trolley with the Vivo 50/60/65 recalled	Breas Medical	Other	Nationwide

Other CPAP & Ventilators recalls

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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