Hazard
51 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 51 misdiagnosis 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 1 (2%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all misdiagnosis 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.
Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.
Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.
GE Healthcare is recalling the AW Server 3.2 ext. 6.5 radiological image processing system due to a software synchronization issue that may cause the wrong patient's images to be displayed without warning, potentially leading to misdiagnosis.
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.
Roche Diagnostics is recalling 1,300 Elecsys Anti-TSHR cassettes because results vary by instrument platform and calibrator lots vary, which may lead to incorrect diagnosis or treatment.
DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.
Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.
Natus Neurology has recalled the OBM00002 OBM DAB (Digital Acquisition Box) because electrode placement labels were applied backwards. This may lead to misdiagnosis of seizure location in neonates monitored with the device.
Echopixel's True 3D Viewer (Model EP-00003) with certain software versions can display ultrasound image orientation incorrectly, potentially leading to misdiagnosis or incorrect surgical planning.
Copan WASP is recalling PhenoMATRIX, an AI-powered bacterial culture plate interpretation software, because it lacks required FDA premarket approval, creating potential risk of inaccurate colony counts and morphology data that could affect patient diagnosis.
Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.
Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.
Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.
Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.
Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or mistreatment.
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.
Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.
Philips recalls 12 units of its Spectral CT Oncology Essentials system because a marking laser could reflect off the gantry cover, potentially causing misdiagnosis and incorrect patient treatment.
The ACUSON Redwood 1.0 Diagnostic Ultrasound System may display the last measured cardiac value instead of the minimum or maximum value as configured, potentially leading to misdiagnosis or improper patient management.
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.