Breas Medical recalls

Breas Medical has 5 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 11 Sep 2024. 3 are still ongoing.

Total recalls5since 2020

Last 12 months0reported

Class I120% of total

Ongoing3latest 11 Sep 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 20%Class II 4 80%Class III 0 0%

Why breas medical is recalled

Other Reasons480%
Device Malfunction120%

Product types

CPAP & Ventilators5100%

By year

2024120%
2023120%
2022240%
2020120%

Ongoing breas medical recalls

3 active

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

All breas medical recalls, newest first

5 total

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
4 Mar 2020Device	CLASS II	Protective Cover Vivo 55/65 (Used for Vivo 50/65) recalled	Breas Medical	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.