FDAFDA · Food and drugs·Recall number Z-1942-2026
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Published May 13, 2026 · Recall initiated: March 25, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Ventec Life Systems, Inc.
- Distributor
- US: OH, GA, CA, MO
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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