FDAFDA · Food and drugs·Recall number Z-2525-2026
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Published July 1, 2026 · Recall initiated: May 8, 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 have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventec Life Systems, Inc.
- Distributor
- US Nationwide distribution in the state of UT.
- Lot
- REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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