VOCSN V+Pro Package
The VOCSN V+Pro respiratory system may leak oxygen, reducing oxygen delivery and increasing fire risk.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Ventec Life Systems, Inc., of Bothell, Washington, began a recall on March 25, 2026, of the VOCSN V+Pro package, REF: PRT-01198-000, and the VOCSN V+Pro unit, REF: PRT-01185-000.
The 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.
The FDA added the recall to its Enforcement Report and classified it on May 1, 2026, with the recall in the weekly enforcement report on May 13, 2026, affecting California, Georgia, Missouri and Ohio.
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:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your package affected?
Match the UDI-DI and reference number listed under your product.
Vocsn V+Pro package
- UDI-DI
- 00855573007914
- 00855573007877
- Reference number
- PRT-01198-000
Vocsn V+Pro unit
- UDI-DI
- 00855573007914
- 00855573007877
- Reference number
- PRT-01185-000
Details
- Company began the recall
- Sold in
- 4 states
- Event ID
- 98554
- Recall No.
- Z-1942-2026
- Company
- Ventec Life Systems, Inc.Bothell, Washington
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
