RegWardenFDA facility compliance records
Company

BREAS MEDICAL, INC.

5 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2020: 1 recalls; 2022: 2 recalls; 2023: 1 recalls; 2024: 1 recalls20172018201912020202122022120231202420252026
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2024-07-25
    There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
  • Class IIOngoing2023-10-13
    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
  • Class IIOngoing2022-06-02
    A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if me…
  • Class IITerminated2022-03-21
    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
  • Class IITerminated2020-01-28
    The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “BREAS MEDICAL, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10046641-breas-medical-inc/

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