PVA — Class II medical device recall Z-2805-2020
Ongoing recall by Precision Valve & Automation,Inc, reported 2020-08-26, distributed nationwide. While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper
| Recall number | Z-2805-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Precision Valve & Automation,Inc, Cohoes, NY, United States |
| Recall initiated | 2020-06-26 |
| Classified | 2020-08-14 |
| Reported by FDA | 2020-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Lot numbers | EV123732 |
| Serial numbers | L1002, L1005, L1006 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2805-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.