VOCSN V+Pro package recalled over fire hazard

Recall date

March 25, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ventec Life Systems, Inc. recalls VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

Recall number

Z-1942-2026

FDA classification

Class I

Brand / firm

Ventec Life Systems, Inc.

Sold / distributed

US: OH, GA, CA, MO

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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