GENOSYL DS — Class I medical device recall Z-2587-2021
Completed recall by Vero Biotech, LLC, reported 2021-10-06, distributed in IL, TX. Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen d
| Recall number | Z-2587-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vero Biotech, LLC, Atlanta, GA, United States |
| Recall initiated | 2021-09-09 |
| Classified | 2021-09-30 |
| Reported by FDA | 2021-10-06 |
| Distributed | IL, TX |
| UPC / GTIN / UDI-DI | 00850000962026 |
| Serial numbers | G0294 |
| Model numbers | 601588-01 |
Product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2587-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.