Hazard
31 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 31 incorrect diagnosis recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (13%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all incorrect diagnosis 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.
iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 because a device malfunction may cause biopsy needles to miss targets, potentially leading to incorrect diagnoses.
Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.
Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.
Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking sample misidentification.
Siemens is recalling 26 Acuson SC2000 ultrasound systems because a software issue causes inaccurate 3D images, which may lead to ablation in the wrong location.
GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.