Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 30, 2021
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
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.
Vero Biotech, LLC recalled GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 - a critical-severity action.
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 was recalled by Vero Biotech, LLC in June 30, 2021. Reason: Reports received of NO measured below desired dose during transition between primary console and backup conso…. Check the official notice for the remedy. Verify recall #Z-1863-2021 with the FDA Devices before acting.
The recall
Vero Biotech, LLC issued this critical-severity FDA Devices recall-Reports received of NO measured below desired dose during transition between primary console and backup conso….
- Critical
- severity level
- 465 units
- affected scope
- Class I
- classification
- June 30, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1863-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1863-2021) was formally reported on June 30, 2021, with the manufacturer initiating the action on May 19, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Vero Biotech, LLC is listed as the recalling firm, operating out of Atlanta, GA. Federal records list the affected scope as 465 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
465 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1863-2021 |
| Date reported | June 30, 2021 |
| Date initiated | May 19, 2021 |
| Recalling firm | Vero Biotech, LLC |
| Firm location | Atlanta, GA |
| Affected scope | 465 units |
| Distribution | Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1863-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860. Recalled by Vero Biotech, LLC. Units affected: 465 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Critical. Recall number: Z-1863-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1863-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 30, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.