FDA Device recall Z-2587-2021
GENOSYL DS (Delivery System) console, for use as a vasodilator
- FDA Device
- Class I
- completed
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class I recall of GENOSYL DS (Delivery System) console, for use as a vasodilator by Vero Biotech, citing manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2587-2021 |
| Classification | Class I |
| Status | completed |
| Initiated | 2021-09-09 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Vero Biotech |
| Distribution | IL, TX |
Product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Reason
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Identifiers
| code_info | Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)0085000096202…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2587-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.