Z-2587-2021Class I

GENOSYL DS (Delivery System) console, for use as a vasodilator

Name: Z-2587-2021 GENOSYL DS (Delivery System) console, for use as a vasodilator
Creator: Vero Biotech, LLC
Published: 2021-09-09
License: https://open.fda.gov/license/

Vero Biotech Inc. / initiated 2021-09-09 / Completed / root cause: manufacturing process

FDA source

Vero Biotech, LLC began a recall of GENOSYL DS (Delivery System) console, for use as a vasodilator on 2021-09-09. FDA classified it as Class I and gives the reason as "Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO)". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2587-2021
Classification: Class I
Status: Completed
Initiated: 2021-09-09
Posted: 2021-09-30
Recalling firm: Vero Biotech Inc.
Product: GENOSYL DS (Delivery System) console, for use as a vasodilator.
Product code: MRN Apparatus, Nitric Oxide Delivery
Reason for recall: Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 09/09/2021, Vero Biotech notified customers via certified mail with letter titled, "URGENT: MEDICAL DEVICE RECALL GENOSYL DS LIMITED MANUFACTURING DEFECT." The letter notified the customer of the issue and there were no actions to be taken as the three affected devices were removed from the field prior and replaced.
Quantity in commerce: 120 consoles (3 consoles affected)
Distribution: Distributed within US to Texas and Illinois.
Product codes and lots: Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)00850000962026(11)200917(21)G0378); and MA000065 (UDI (01)00850000962026(11)210511(21)MA000065)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2587-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2587-2021	Class I	Completed	Voluntary: Firm initiated	2021-10-06	2021-09-30

Product code MRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)