Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1942-2026 — VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

U.S. FDA — Device Enforcement · United States · 2026-03-25 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1942-2026
Date of alert
2026-03-25
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Ventec Life Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00855573007914
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.