Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

GENOSYL DS Recalled by Vero Biotech, LLC Due to Reports received of NO measured below desired dose...

Date: May 19, 2021
Company: Vero Biotech, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Vero Biotech, LLC directly.

Affected Products

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

Quantity: 465 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Vero Biotech, LLC

Vero Biotech, LLC has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report