# FDA recall Z-2587-2021

> **Vero Biotech, LLC** · Class I · device recall initiated 2021-09-09.

## Product

GENOSYL DS (Delivery System) console, for use as a vasodilator.

## Reason for recall

Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).

## Distribution

Distributed within US to Texas and Illinois.

## Key facts

- **Recall number:** Z-2587-2021
- **Recalling firm:** Vero Biotech, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-09-09
- **Report date:** 2021-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2021

## Citation

> AI Analytics. FDA recall Z-2587-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-2587-2021. Source: US FDA. Licensed CC0.

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