Reported May 13, 2026 · Ongoing
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Ventec Life Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ventec Life Systems, Inc. · 22002 26th Ave Se · Bothell, WA · 98021-4903
Is this the product you have?
- VOCSN V+Pro package
- REFPRT-01198-000; VOCSN V+Pro unit
- REFPRT-01185-000
- Lot codes and dates
- 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)
152884152885152886152887152888152889152890152891152892152893152895152896152897152898152899152900152901152902152903152904152908152909152910152911152912152913152914152915152916152917152918152919152986152987155236156507156512156515156516156517156524156532
- Amount recalled
- 42
Where it was sold
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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