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 | Terminated |
| Reason | 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. |
| Product | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 |
| Quantity | 465 units |
| Distribution | Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC |
| Initiated | 2021-05-19 |
| Classified | 2021-06-23 |
| Terminated | 2023-10-12 |
| Recall number | Z-1863-2021 |
| 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-1863-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87764/
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