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.
Becton Dickinson is recalling 124 BD Veritor System Readers due to background calibration issues that may cause false positive or negative test results.
Becton Dickinson & Co. is recalling 32 BD Veritor Plus Analyzers because background calibration issues may cause false positive or negative test results.
Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.
Beekley Corporation is recalling TomoSPOT skin markers used in mammography because they may create imaging artifacts that mimic calcifications on patient mammograms.
Beekley Corporation is recalling O-SPOT REF 791 and 791S skin markers because they may create imaging artifacts that mimic calcifications on mammograms.
Beekley Corporation is recalling S-SPOT REF 777 and 777S markers because they may create imaging artifacts that mimic calcifications on mammograms.
Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states that could lead to patient misdiagnosis.
Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.
Becton Dickinson is recalling specific lots of BD Vacutainer K2 EDTA blood collection tubes because they may contain insufficient anticoagulant, potentially causing erroneous test results.
Biomerieux Inc is recalling VITEK 2 Gram Negative test kits containing colistin because they produced high rates of major errors in susceptibility testing.
Agfa Healthcare is recalling NX 3.0.8950 software because it may temporarily display and transmit incorrect patient images to PACS systems.
Merge Healthcare is recalling specific versions of Merge PACS software because a display defect may cause image lines to shift, potentially leading to physician misdiagnosis.
Merge Healthcare is recalling specific versions of Merge PACS software because unviewed images may not display correctly, posing a risk of physician misdiagnosis.
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems due to a software anomaly that may cause sample ID misassociation, potentially leading to misdiagnosis.
GE Healthcare is recalling Vivid Ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.
GE Healthcare is recalling Vivid E95, E90, and E80 ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.
Siemens is recalling IMMULITE 2000 Progesterone kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.
Great Basin Scientific is recalling the Staph ID/R Blood Culture Panel because the S. aureus probe could result in false positive results.
Merge Healthcare is recalling Merge PACS software because it may fail to display unviewed images, potentially leading to physician misdiagnosis.
Ortho-Clinical Diagnostics is recalling VITROS Calcium Slides due to potential negatively biased results that may affect diagnosis.
Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Total Beta-hCG II Reagent Packs and Calibrators because they may generate false positive results for hCG levels.
Siemens is recalling 37 SOMATOM Force CT systems because a software error in the Neonate Head protocol may cause image artifacts, potentially leading to misdiagnosis.
Philips Medical Systems is recalling the AutoSPECT Pro software application because it may produce erroneous results when processing cardiac SPECT data acquired at detector angles other than 90 or 180 degrees.
Siemens is recalling Dimension Vista Estradiol tests because the drug fulvestrant may cause falsely elevated results.