Hazard
102 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 102 misdiagnosis recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (10%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all misdiagnosis 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.
Philips is recalling 219 EPIQ Elite Diagnostic Ultrasound Systems due to a software issue that may cause inaccurate blood flow velocity measurements and potential misdiagnosis.
Nova Biomedical is recalling StatStrip Glucose and B-Ketone meters because a software defect may cause patient data to be assigned to the wrong medical record.
GE Healthcare is recalling Workflow Core Services V8 because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
GE Healthcare is recalling Core Services Hub V8 software because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
GE Healthcare is recalling Enterprise Archive V8 software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis.
GE Healthcare is recalling 116 Centricity PACS Server V7 systems because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.
GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.
Beckman Coulter is recalling MicroScan LabPro V5.03 Panel Update 11 DVD Kits due to incorrect algorithms that may affect antimicrobial susceptibility test results, potentially leading to false susceptibility classifications.
Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.
Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.
Philips is recalling Vue PACS Diagnostic Viewer software versions 12.1.5 to 12.2.8.454 because a defect may cause incorrect ischemic map calculations, potentially leading to misdiagnosis.
Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.
Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.
The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.
Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.
Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.
Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.
Philips is recalling 5 Incisive CT Plus CT X-ray systems due to potential defects that may display images with flipped or reversed orientation, risking misdiagnosis, incorrect treatment, and unnecessary radiation exposure from repeat scans.
Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.
Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.