Vero Biotech GENOSYL DS Nitric Oxide System May Not Deliver Proper Dose
Vero Biotech recalls GENOSYL DS nitric oxide delivery system with serial numbers listed; reports of insufficient nitric oxide delivery during console transitions after software update 2.2.3.
Lower-risk 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.
Contact the company
What happened, in plain English
Vero Biotech is recalling their GENOSYL DS nitric oxide delivery system because reports indicate it may not deliver the proper dose of nitric oxide when switching between primary and backup consoles after a specific software update. This could affect medical treatment effectiveness. Read more at govinfonow.com/recall/62504-vero-biotech-genosyl-ds-nitric-oxide-system-may-not-deliver.
Source Summary by GovInfoNow · govinfonow.com/recall/62504-vero-biotech-genosyl-ds-nitric-oxide-system-may-not-deliver · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1863-2021
Cite this page
“Vero Biotech GENOSYL DS Nitric Oxide System May Not Deliver Proper Dose.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62504-vero-biotech-genosyl-ds-nitric-oxide-system-may-not-deliver. Based on FDA recall #Z-1863-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1863-2021%22&limit=1).
Why it’s dangerous
The system may not deliver the correct nitric oxide dose when switching between the primary and backup consoles after software version 2.2.3 was updated. This could lead to improper medical treatment.
Who’s affected
Patients using the GENOSYL DS system for medical nitric oxide delivery are affected. Those with the specific serial numbers listed in the recall are most at risk.
How to tell if you have this one
Check if your GENOSYL DS system has a serial number listed in the provided list (e.g., G0803, G0807, etc.). The product was sold with software version 2.2.3 or later.
- Brand
Vero Biotech- Category
Medical device
What to do — step by step
Check Serial Number
Verify your GENOSYL DS system's serial number against the list provided in the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Kansas, Louisiana, Maryland, Minnesota, North Carolina, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1863-2021 (May 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1863-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.