The Recall Desk

Manufacturer

INNOVA MEDICAL GROUP, INC.

3 recalls in our database name INNOVA MEDICAL GROUP, INC. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
3
Most recent
2021-06-16

Of the 3 recalls from INNOVA MEDICAL GROUP, INC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (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.

1–3 of 3

  • SevereFDA (Devices)·Z-1539-2021·2021-06-16

    COVID-19 Self-Test Kit Distributed Without Clinical Investigation Authorization

    Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 3T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1538-2021·2021-06-16

    INNOVA SARS-CoV-2 Antigen Rapid Tests Recalled for Unauthorized Non-Clinical Distribution

    INNOVA Medical Group is recalling SARS-CoV-2 antigen rapid test kits distributed to customers not enrolled in an authorized clinical investigation.

    Product
    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1537-2021·2021-06-16

    FDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution

    Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 7T
    Category
    Medical Device
    Distribution
    Distributed nationwide