The Recall Desk

Manufacturer

MELA Sciences, Inc.

1 recall in our database name MELA Sciences, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2015-05-27

Of the 1 recalls from MELA Sciences, 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

  • ModerateFDA (Devices)·Z-1636-2015·2015-05-27

    MelaFind Device Recalled for Unapproved User Interface Data Display

    MELA Sciences is recalling 65 MelaFind devices because the probability and histogram data displayed in the user interface lacks FDA approval.

    Product
    MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
    Category
    Medical Device
    Distribution
    21 states