Precision Valve & Automation, Inc PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.
Brand
Precision Valve & Automation, Inc
Lot Codes / Batch Numbers
Lot #: EV123732 Serial #s: L1002, L1005, L1006
Products Sold
Lot #: EV123732 Serial #s: L1002, L1005, L1006
Precision Valve & Automation, Inc is recalling PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COV due to While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The resul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.
Recommended Action
Per FDA guidance
Customers will be e-mailed initial recall notice, followed by written letter. Customers will be directed to ship recalled PreVENT back to PVA as soon as possible. Recalled unit will be shipped back to PVA in the same packaging from replacement unit. Recalled units will be scrapped at PVA.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026