FDAClass I · Medical device · Recalled May 13, 2026

VOCSN V+Pro package recall — Ventec Life Systems, Inc.

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

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1942-2026
Brand: Ventec Life Systems
Classification: Class I
Units affected: 42
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

VOCSN V+Pro package

Companies & origin

Recalling firm location: Bothell, WA, United States
Firm address: 22002 26th Ave Se, 98021-4903

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532
Distribution: US: OH, GA, CA, MO
FDA event ID: 98554
Recall initiated: March 25, 2026
FDA classified: May 1, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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