Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 26, 2020
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.
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 al…
Precision Valve & Automation,Inc recalled PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients sufferi… - a moderate-severity action.
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients sufferi… was recalled by Precision Valve & Automation,Inc in August 26, 2020. Reason: While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper…. Check the official notice for the remedy. Verify recall #Z-2805-2020 with the FDA Devices before acting.
The recall
Precision Valve & Automation,Inc issued this moderate-severity FDA Devices recall-While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- August 26, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2805-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2805-2020) was formally reported on August 26, 2020, with the manufacturer initiating the action on June 26, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Precision Valve & Automation,Inc is listed as the recalling firm, operating out of Cohoes, NY. Federal records list the affected scope as 3 units.
The documented reason for this recall is: 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 resul… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2805-2020 |
| Date reported | August 26, 2020 |
| Date initiated | June 26, 2020 |
| Recalling firm | Precision Valve & Automation,Inc |
| Firm location | Cohoes, NY |
| Affected scope | 3 units |
| Distribution | Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2805-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Precision Valve & Automation,Inc. Units affected: 3 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2805-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2805-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 26, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.