# FDA recall Z-1863-2021

> **Vero Biotech, LLC** · Class I · device recall initiated 2021-05-19.

## Product

GENOSYL DS; Nitric Oxide Delivery System    Combination Product NDA202860

## Reason for recall

Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

## Distribution

Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC

## Key facts

- **Recall number:** Z-1863-2021
- **Recalling firm:** Vero Biotech, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-19
- **Report date:** 2021-06-30
- **Termination date:** 2023-10-12

- **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-1863-2021

## Citation

> AI Analytics. FDA recall Z-1863-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1863-2021. Source: US FDA. Licensed CC0.

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