The Recall Desk

Hazard

Treatment Error Risk recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2024-02-28

Of the 2 treatment error risk 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 treatment error risk 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.

1–2 of 2

  • HighFDA (Devices)·Z-1171-2024·2024-02-28

    Cardiology imaging software may calculate heart chamber size incorrectly

    Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.

    Product
    Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2022·2022-07-06

    FDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges

    Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent kits because the reference ranges in the instructions have shifted. Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.

    Product
    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
    Category
    Medical Device
    Distribution
    Distributed nationwide