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Ongoing FDAEvent 98888 (3 months ago)

Ventec Life Systems VOCSN+Pro Package

The VOCSN+Pro respiratory system may have a damaged backup battery, causing the backup alarm not to activate during power loss.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Ventec Life Systems, Inc., of Bothell, Washington, recalled the VOCSN+Pro package, which includes the VOCSN+Pro unit, because the respiratory system, intended to provide continuous or intermittent ventilator support, may have a damaged back-up battery that supports the backup alarm function.

This damage may result in the backup alarm not activating during loss of primary power and absence or depletion of backup power sources, potentially delaying caregiver awareness of a hazardous condition. The company began the recall on May 8, 2026, and the FDA added it to its Enforcement Report on June 23, 2026, with distribution in the state of Utah.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your package affected?

Affected if its UDI-DI, lot code and reference number are listed under that product.

  1. VOCSN+Pro package

    UDI-DI
    • 00855573007839
    • 00855573007792
    Reference number
    • PRT-00853-000
    Lot
    • PRT-00853-000
    • 155391P
    • 807138
    • PRT-00490-001
    • 155391
    • 804613
  2. VOCSN+Pro unit

    UDI-DI
    • 00855573007839
    • 00855573007792
    Reference number
    • PRT-00490-001
    Lot
    • PRT-00853-000
    • 155391P
    • 807138
    • PRT-00490-001
    • 155391
    • 804613

Details

Company began the recall
Sold in

US Nationwide distribution in the state of Utah.

Event ID
98888
Recall No.
Z-2525-2026
Company
Ventec Life Systems, Inc.Bothell, Washington
Recall type
Voluntary: Firm initiated
Customers told by
Letter
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from Ventec Life Systems, Inc.

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration