The Recall Desk

Manufacturer

NIHON KOHDEN ORANGEMED, INC

1 recall in our database name NIHON KOHDEN ORANGEMED, INC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-09-15

Of the 1 recalls from NIHON KOHDEN ORANGEMED, INC 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

  • HighFDA (Devices)·Z-2435-2021·2021-09-15

    Nihon Kohden NKV-550 Ventilator Recalled for Defective Pressure Regulator

    Nihon Kohden NKV-550 Ventilators with certain serial numbers have a defective gas inlet pressure regulator that could cause malfunction or device check failure. The recall affects 1,999 units distributed globally.

    Product
    Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
    Category
    Medical Device
    Distribution
    Distributed nationwide