Class I — Vero Biotech, LLC
| Recalling firm | Vero Biotech Inc. |
|---|---|
| Registered facility | VERO BIOTECH INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Completed |
| Reason | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). |
| Product | GENOSYL DS (Delivery System) console, for use as a vasodilator. |
| Quantity | 120 consoles (3 consoles affected) |
| Distribution | Distributed within US to Texas and Illinois. |
| Initiated | 2021-09-09 |
| Classified | 2021-09-30 |
| Recall number | Z-2587-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Vero Biotech, LLC (Z-2587-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88558/
Alerts for Vero Biotech Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.