Home / Recalls / Medical Devices
Ventec Life Systems, Inc. recalls VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Recalled May 13, 2026 · FDA recall Z-1942-2026 · Ventec Life Systems
Hazard
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 · FDA Class I
Units
42
Sold at
US: OH, GA, CA, MO
Description
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
Product
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Manufacturer(s)
Ventec Life Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →