The Recall Desk

Manufacturer

INO Therapeutics (dba Ikaria)

4 recalls in our database name INO Therapeutics (dba Ikaria) as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2017-02-01

Of the 4 recalls from INO Therapeutics (dba Ikaria) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • HighFDA (Devices)·Z-1076-2017·2017-02-01

    INOmax DSIR Plus Delivery System Recalled for Inaccurate Valve Calibration

    INO Therapeutics is recalling 45 INOmax DSIR Plus delivery systems because an out-of-tolerance manometer may cause inaccurate valve calibration.

    Product
    Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1223-2015·2015-03-11

    Ikaria INOmax DSIR Nitric Oxide Delivery System Recalled for Alarm Defect

    INO Therapeutics is recalling 45 INOmax DSIR units because a specific software and display combination may trigger false alarms, interrupting nitric oxide therapy.

    Product
    Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2015·2014-12-17

    INOmax DSIR Nitric Oxide System Recalled for Monitoring Error

    INO Therapeutics is recalling nine INOmax DSIR Nitric Oxide delivery systems because they may report lower-than-expected NO concentrations.

    Product
    INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal In
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1528-2014·2014-05-14

    INOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly

    INO Therapeutics is recalling 22 INOmax DSIR Nitric Oxide Delivery Systems due to a software anomaly that may trigger unintended alarms.

    Product
    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The prim
    Category
    Medical Device
    Distribution
    Distributed nationwide