Hazard
118 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 118 software anomaly recalls we have scored against our rubric, 4 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (8%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all software anomaly 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.
Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.
Plum Solo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Plum Duo Infusion Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Plum Duo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
The Ivenix Infusion System Large Volume Pump software is being recalled because a software anomaly can report a false battery-health value and trigger a shutdown alarm.
Philips Azurion 5M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable.
Philips Azurion 7B20/15 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable. 156 units affected.
Hitachi is recalling one Proton Beam Therapy System due to a software anomaly in the patient positioning system that may cause positional discrepancy during treatment.
Hitachi is recalling its Proton Beam Therapy system due to a software anomaly in the patient positioning system that may cause positional discrepancies during treatment.
Fresenius Kabi USA is recalling Ivenix Infusion System LVP software versions 5.10.1 and earlier, which the firm states contain anomalies with the potential to cause serious patient harm or death.
Fresenius Medical Care is recalling 115 5008X CAREsystem units over several software anomalies with the potential to impact patient treatment, one of which may result in treatment stop.
Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.
Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 17 units of its Surgical Navigation Advanced Platform because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling three units of its BrainSTORM Surgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40700BAX, over software anomalies that may cause a blank Run screen or a false motor movement system error. 22,703 units are affected.
Baxter is issuing an urgent correction for Novum IQ Large Volume Pumps over software anomalies that may result in a blank Run screen. 43,922 units are affected.
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.
VITROS 4600 Chemistry Systems are being recalled because a software anomaly can allow results to be reported using diluent packs the system treats as expired, which can produce erroneous results.
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software error that displays an incorrect 9-grid overlay instead of the correct 15-grid overlay in Live or Record mode, affecting measurement accuracy with OptiCross 18 catheters.