Home › Device types › MRN
Apparatus, Nitric Oxide Delivery
FDA product code MRN · Class 2 · Anesthesiology
65
Registered devices
2,071
Adverse events
18
Recalls
33
510(k) clearances
Devices with this code
NOxBOXi — NOXBOX LTDNOxBOXi — NOXBOX LTDINOmax — Mallinckrodt Manufacturing LLCGENOSYL® — VERO BIOTECH INC.NOxBOXi NOXKIT — VERO BIOTECH INC.GENOSYL® — VERO BIOTECH INC.INOmax — Mallinckrodt Manufacturing LLCGENOSYL® — VERO BIOTECH INC.GENOSYL® — VERO BIOTECH INC.NOxBOXi — NOXBOX LTDNOxBOXi — NOXBOX LTDNOxBOXi — NOXBOX LTDNOxBOXi NOXKIT — VERO BIOTECH INC.INOmax — Mallinckrodt Manufacturing LLCINOmax — Mallinckrodt Manufacturing LLCNOxBOXi — NOXBOX LTDUlspira TS — Airgas Therapeutics, LLCNOxBOXi NOXKIT — VERO BIOTECH INC.INOmax — Mallinckrodt Manufacturing LLCNOxBOXi NOXKIT — VERO BIOTECH INC.GENOSYL® — VERO BIOTECH INC.GENOSYL® — VERO BIOTECH INC.INOmax — Mallinckrodt Manufacturing LLCGENOSYL® — VERO BIOTECH INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-14 | NOXBOX LTD | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors. |
| 2026-08-19 | NOXBOX LTD | Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. |
| 2025-09-09 | NOXBOX LTD | The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for |
| 2025-09-09 | NOXBOX LTD | Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requ |
| 2023-11-17 | Vero Biotech, LLC | Cassette did not meet an 1n-process flow criterion. |
| 2023-07-19 | NOXBOX LTD | Replacement of the internal Sample Pump due to high failure rates. |
| 2023-05-03 | NOXBOX LTD | Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas |
| 2022-06-23 | Mallinckrodt, LLC. | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufac |
| 2021-09-09 | Vero Biotech, LLC | Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO). |
| 2021-05-19 | Vero Biotech, LLC | 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 con |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.