Reported Jul 1, 2026 · Ongoing
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Ventec Life Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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+Pro package
- REFPRT-00853-000; VOCSN+Pro unit
- REFPRT-00490-001
- Lot codes and dates
- REF/UDI-DI/Serial Number/Lot
PRT-00853-000/00855573007839/155391P/807138PRT-00490-001/00855573007792/155391/804613
- REF/UDI-DI/Serial Number/Lot
- Amount recalled
- 1
Where it was sold
- Nationwide
- UT
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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