Ventec Life Systems, Inc. recalls VOCSN V+Pro package

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

On 3/25/2026 recall notices were mailed to customers who were asked to do the following: 1. Immediately discontinue use of affected devices. 2. Inspect current stock, quarantine/segregate any unused affected products, remove affected devices from clinical service and segregate to prevent further use. 3. Use a non-affected ventilator for patient support. 4. If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification. 5. Complete and return the response form via email to Ventec-Recall@reacthealth.com 6. If you are no longer the owner of any of these devices, you need to complete an ownership transfer form at: VentecLife.com/tracking so firm can follow up with the current owner of the impacted device(s). If you have questions, you can contact the firm at 844-698-6276

• FDA enforcement recordOfficial FDA database entry for Z-1942-2026
• FDA 510(k) clearance · K162877The device's official FDA premarket clearance record
• FDA device classification · NOUOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5895The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ventec Life Systems, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.