GENOSYL DS — Class I medical device recall Z-1863-2021
Terminated recall by Vero Biotech, LLC, reported 2021-06-30, distributed nationwide. Reports received of NO measured below desired dose during transition between primary console and backup consol
| Recall number | Z-1863-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vero Biotech, LLC, Atlanta, GA, United States |
| Recall initiated | 2021-05-19 |
| Classified | 2021-06-23 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2023-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 465 units |
| Reason classes | software |
| Serial numbers | G0094, G0109, G0110, G0111, G0124, G0125, G0129, G0131, G0133, G0135, G0136, G0137, G0138, G0139, G0140, G0143, G0146, G0147, G0149, G0155, G0157, G0158, G0159, G0160, G0162 and 439 more |
| Model numbers | 601588-01 |
Product
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Reason for recall
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
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-1863-2021. 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.