The Recall Desk

Manufacturer

Simple Diagnostics, Inc.

1 recall in our database name Simple Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2018-01-03

Of the 1 recalls from Simple Diagnostics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) 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

  • SevereFDA (Drugs)·D-0134-2018·2018-01-03

    Simple Diagnostics Recalls Alcohol Prep Pads Due to Sterility Concerns

    Simple Diagnostics is recalling 150,250 alcohol prep pads because the company cannot ensure they are sterile and due to cGMP deviations.

    Product
    Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
    Category
    Medical Device
    Distribution
    0 states