Vero Biotech, LLC: Medical Device Recall in 2021 - (Recall #: Z-2587-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 9, 2021

Date Posted: October 6, 2021

Recall Number: Z-2587-2021

Event ID: 88558

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).

Status: Completed

Product Quantity: 120 consoles (3 consoles affected)

Code Information:

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)

Distribution Pattern:

Distributed within US to Texas and Illinois.

Voluntary or Mandated:

Voluntary: Firm initiated