Official recall record

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

US FDA — Medical Devices · 2026-03-25 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Alert date: 2026-03-25
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 00855573007914
Brand on record: Ventec Life Systems, Inc.

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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