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

Class I

Recalling firm: Ventec Life Systems, Inc.
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 pattern: US: OH, GA, CA, MO
State: WA
Status: Ongoing
Recall number: Z-1942-2026
Recall initiated: March 25, 2026