The Recall Desk

Manufacturer

Kowa Optimed Inc

1 recall in our database name Kowa Optimed Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2020-12-23

Of the 1 recalls from Kowa Optimed 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-0636-2021·2020-12-23

    Kowa VK-2s Software Recall for Potential Patient Data Deletion

    Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.

    Product
    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
    Category
    Medical Device
    Distribution
    Distributed nationwide