The Recall Desk

Manufacturer

Monarch Medical Technologies

2 recalls in our database name Monarch Medical Technologies as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2019-11-20

Of the 2 recalls from Monarch Medical Technologies we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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.

1–2 of 2

  • HighFDA (Devices)·Z-0354-2020·2019-11-20

    Monarch Medical Technologies Recalls EndoTool SubQ Software Versions

    Monarch Medical Technologies is recalling EndoTool SubQ software versions 1.7.1, 1.7.4, and 1.7.5 because the product was distributed prior to FDA approval or clearance.

    Product
    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1786-2019·2019-06-26

    Monarch EndoTool IV Software Recalled for High Insulin Dosing Calculations

    Monarch Medical Technologies is recalling EndoTool IV software versions 1.8 through 1.10 because insulin dosing calculations were erroneously high.

    Product
    Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
    Category
    Medical Device
    Distribution
    Distributed nationwide