The Recall Desk

Manufacturer

INO therapeutics LLC/dba ikaria

1 recall in our database name INO therapeutics LLC/dba ikaria as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-08-15

Of the 1 recalls from INO therapeutics LLC/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.

1–1 of 1

  • ModerateFDA (Devices)·Z-2733-2018·2018-08-15

    INOmeters for INOflo Cylinders Recalled Due to Incorrect Expiration Date Programming

    INO therapeutics LLC is recalling 108 INOmeter devices affixed to INOflo cylinders in Japan because they were programmed with an incorrect expiration date.

    Product
    Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder
    Category
    Medical Device
    Distribution
    0 states