Stop using nowMedical device recall · FDA · Published September 9, 2021
Vero Biotech GENOSYL DS Console Recall: Nitrogen Dioxide Delivery Hazard
Vero Biotech recalls GENOSYL DS consoles for vasodilator use due to manufacturing defect causing nitrogen dioxide instead of nitric oxide delivery. Affected units have specific model and serial numbers.
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
“Vero Biotech GENOSYL DS Console Recall: Nitrogen Dioxide Delivery Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61818-vero-biotech-genosyl-ds-console-recall-nitrogen-dioxide-delivery-hazard. Based on FDA recall #Z-2587-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2587-2021%22&limit=1).
Vero Biotech, LLC voluntarily recalled GENOSYL DS consoles on Sept. 9, 2021, after the FDA announced a Class I recall due to a manufacturing defect that could deliver nitrogen dioxide instead of nitric oxide. The Food and Drug Administration issued the recall for devices distributed in Texas and Illinois.
How to tell if you have it
GENOSYL DS (Delivery System) console
Model Number: 601588-01
Serial Numbers G0294, G0378, MA000065
UPC 00850000962026
The hazard
The recall involves a manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Vero Biotech has two other recalls on record since May 19, 2021. On Nov. 17, 2023, the company recalled Genosyl DS cassettes because they did not meet an in-process flow criterion. Other recent recalls of similar products include NOXBOX Nitric Oxide Delivery System Recall (Aug. 19, 2026) and NOxBOXi Nitric Oxide Delivery System recall (Sept. 14, 2026).
How to tell if you have this one
Check for model number 601588-01 and serial numbers G0294, G0378, or MA000065. The console is sold for medical vasodilator use and has specific UDI codes associated with these serial numbers.
Brand
Vero Biotech
Product
GENOSYL DS (Delivery System) console, for use as a vasodilator
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Console Now
Immediately stop using the GENOSYL DS console if you have it. The defect causes dangerous gas delivery that could cause serious health risks.
Where it went and when
Where it was distributed
Distributed in Illinois and Texas.
Listed by the agency
Not listed
FDA distribution: “Distributed within US to Texas and Illinois.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Texas.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2587-2021 (September 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2587-2021 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.