The Recall Desk

Hazard

Unauthorized Modification recalls

4 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2022-07-27

Of the 4 unauthorized modification recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unauthorized modification recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–4 of 4

  • HighFDA (Devices)·Z-1450-2022·2022-07-27

    LumiraDx SARS-CoV-2 Antibody Test Strip Modified Outside Approved Scope

    LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.

    Product
    LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1451-2022·2022-07-27

    LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification

    LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.

    Product
    LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2139-2018·2018-06-20

    Ion Beam Applications Recalls Proteus ONE and Plus Devices

    Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.

    Product
    Proteus ONE and Proteus Plus
    Category
    Medical Device
    Distribution
    0 states