GENOSYL DS Console (Vero Biotech) – Gas Line Reversal Risk (2021)
Manufacturing defect can deliver incorrect gas, potentially causing serious medical harm.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Brand
Vero Biotech, LLC
Lot Codes / Batch Numbers
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)
Products Sold
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)
Vero Biotech, LLC is recalling GENOSYL DS (Delivery System) console, for use as a vasodilator. due to Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, TX
Page updated: Jan 10, 2026