Hazard Type

Software Defect Recalls

1,491 product recalls involving software defect. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

1,491Total Recalls
113Critical
36.5MUnits Affected
All Recalls

Every Software Defect Recall

Sorted by most recent. Click any recall for full details and safety information.

1,491 recalls
High RiskFDA
Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for O...
Medical Devices·833 affected·Sep 18, 2025
High RiskFDA
Medicalcommunications Gmbh
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medic...
Medical Devices·474 affected·Sep 9, 2025
CriticalFDA
Draeger, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The At...
Respiratory Devices·530 affected·Sep 9, 2025
CriticalFDA
Draeger, Inc.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The ...
Respiratory Devices·223 affected·Sep 9, 2025
High RiskFDA
Wipro Ge Healthcare Private Ltd.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, c...
Medical Devices·2,306 affected·Sep 5, 2025
High RiskFDA
Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Prod...
Medical Devices·1 affected·Sep 5, 2025
High RiskFDA
Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Versi...
Medical Devices·16,898 affected·Sep 5, 2025
High RiskFDA
Wipro Ge Healthcare Private Ltd.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, c...
Medical Devices·173 affected·Sep 5, 2025
High RiskFDA
Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Versi...
Medical Devices·820 affected·Sep 5, 2025
CriticalFDA
Dexcom, Inc.
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: ...
Diabetes Devices·333 affected·Aug 28, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L211 PROPONENT DR SL MRI Pacemaker
Cardiac Devices·106,536 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number S702, ALTRUA 2 DR SL Pacemaker
Cardiac Devices·4,055 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U128, VALITUDE CRT-P EL MRI
Medical Devices·28,911 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L231, PROPONENT DR EL MRI Pacemaker
Cardiac Devices·63,851 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L101, ESSENTIO DR SL Pacemaker
Cardiac Devices·22,714 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Cardiac Devices·3,146 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U226, VISIONIST CRT-P EL
Medical Devices·1,050 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
PROPONENT SR SL (Model L200)
Medical Devices·1,380 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Medical Devices·41,191 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L221 PROPONENT DR EL Pacemaker
Cardiac Devices·3,592 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Cardiac Devices·190,088 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Medical Devices·34,180 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L121 ESSENTIO DR EL Pacemaker
Cardiac Devices·10,833 affected·Aug 20, 2025
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA0001...
Medical Devices·2,278 affected·Aug 15, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Radiology Solutions software version 14.2.2
Medical Devices·12 affected·Aug 13, 2025
High RiskFDA
Beta Bionics, Inc.
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Medical Devices·15 affected·Aug 13, 2025
High RiskFDA
Agilent Technologies Denmark Aps
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Vers...
Medical Devices·4,145 affected·Aug 11, 2025
High RiskFDA
Agilent Technologies Denmark Aps
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Ver...
Medical Devices·67 affected·Aug 11, 2025
High RiskFDA
Agilent Technologies Denmark Aps
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Ve...
Medical Devices·65 affected·Aug 11, 2025
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model ...
Cardiac Devices·84 affected·Aug 11, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pac...
Medical Devices·6 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1,...
Medical Devices·2 affected·Aug 8, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular, Software 8.0.0.4.
Medical Devices·4 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pac...
Medical Devices·3 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1...
Medical Devices·26 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Ser...
Medical Devices·0 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pac...
Medical Devices·3 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pa...
Medical Devices·13 affected·Aug 8, 2025
High RiskFDA
Tandem Diabetes Care, Inc.
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide whe...
Diabetes Devices·122,958 affected·Aug 5, 2025
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18...
Medical Devices·810 affected·Aug 5, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Medical Devices·10,101 affected·Aug 4, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Medical Devices·43,922 affected·Aug 4, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The No...
Medical Devices·2 affected·Jul 24, 2025
High RiskFDA
Dentsply Ih, Inc.
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product...
Medical Implants·102 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and No...
Medical Devices·55 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The No...
Medical Devices·1 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoT...
Medical Devices·80 affected·Jul 24, 2025
High RiskFDA
Insightra Medical Inc
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25,...
Cardiac Devices·24,227 affected·Jul 19, 2025