# FDA recall Z-1942-2026

> **Ventec Life Systems, Inc.** · Class I · device recall initiated 2026-03-25.

## Product

VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

## Reason for recall

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

## Distribution

US: OH, GA, CA, MO

## Key facts

- **Recall number:** Z-1942-2026
- **Recalling firm:** Ventec Life Systems, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-25
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1942-2026

## Citation

> AI Analytics. FDA recall Z-1942-2026. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-1942-2026. Source: US FDA. Licensed CC0.

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