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Apparatus, Nitric Oxide Delivery
FDA product code MRN · Class 2 · Anesthesiology
58
Registered devices
2,049
Adverse events
16
Recalls
33
510(k) clearances
Devices with this code
INOmax — Mallinckrodt Manufacturing LLCINOmax — Mallinckrodt Manufacturing LLCGENOSYL® — VERO BIOTECH INC.NOxBOXi — NOXBOX LTDAeroNOx Nitric Oxide Delivery Device — INTERNATIONAL BIOMEDICAL, LTD.INOmax — Mallinckrodt Manufacturing LLCINOmax — Mallinckrodt Manufacturing LLCGENOSYL® — VERO BIOTECH INC.Ulspira TS — Airgas Therapeutics, LLCNOxBOXi — NOXBOX LTDNOxBOXi — NOXBOX LTDGENOSYL® — VERO BIOTECH INC.GENOSYL® — VERO BIOTECH INC.INOmax — Mallinckrodt Manufacturing LLCINOmax — Mallinckrodt Manufacturing LLCGENOSYL® — VERO BIOTECH INC.INOmax DSIR Plus MRI — Mallinckrodt Manufacturing LLCNOxBOXi — NOXBOX LTDGENOSYL® — VERO BIOTECH INC.NOxBOXi — NOXBOX LTDAeroNOx 2.0 Nitric Oxide Delivery Device — INTERNATIONAL BIOMEDICAL, LTD.INOmax — Mallinckrodt Manufacturing LLCGENOSYL® — VERO BIOTECH INC.NOxBOXi — NOXBOX LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2018-07-09 | INO therapeutics LLC/dba ikaria | INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to |
| 2016-11-21 | INO Therapeutics (dba Ikaria) | Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve |
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