Breas Medical, Inc. FDA Recalls

4 recalls on file across devices, 1 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patiClass IJul 25, 2024There is a potential for short term (<7 days) elevated level	There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the	Class IDevices	Jul 25, 2024
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator deClass IIOct 13, 2023Produced with unintended open slits on the side of the mouth	Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation	Class IIDevices	Oct 13, 2023
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals whoClass IIJun 2, 2022A forced shutdown of one of the processors did not generate	A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AN	Class IIDevices	Jun 2, 2022
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384Class IIMar 21, 2022Ventilator mounting brackets for the Vivo 50/60/65 and Vivo	Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from th	Class IIDevices	Mar 21, 2022