Class I

Medical Device Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Ventec Life Systems, Inc. · March 25, 2026

Reason for Recall

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

Distribution

US: OH, GA, CA, MO

States Affected

CA, GA, MO, OH

Quantity Affected

42

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1942-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Ventec Life Systems, Inc. Medical Device Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 | SafeCheck