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 (Delivery System) console Recalled by Vero Biotech, LLC Due to Manufacturing defect involving reversal of the inlet and...

Date: September 9, 2021
Company: Vero Biotech, LLC
Status: Completed
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 (Delivery System) console, for use as a vasodilator.

Quantity: 120 consoles (3 consoles affected)

Why Was This Recalled?

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

Where Was This Sold?

Distributed within US to Texas and Illinois.

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