Facility

BREAS MEDICAL, INC.

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

Key facts

5recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010817335
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	16 Esquire Road N Billerica, MA, US 01862
Registration status	Active · expires 2026
Parent company	BREAS MEDICAL, INC. (owner-operator 10046641)
Brand names	Vivo Accessories

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Circuit, Breathing (W Connector, Adaptor, Y Piece)
Product code CAI (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5240

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.

FDA inspections (2)

NAI2022-01-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2020-02-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by BREAS MEDICAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BREAS MEDICAL, INC. (FEI 3010817335) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010817335-breas-medical-inc/

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