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
Quest International, Inc.
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software ...
Diagnostic Devices·376 affected·Jul 17, 2025
High RiskFDA
Maquet Gmbh
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software ...
Medical Devices·315 affected·Jul 14, 2025
High RiskFDA
Spineart Sa
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version:...
Medical Devices·0 affected·Jun 30, 2025
High RiskFDA
Spineart Sa
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version:...
Medical Devices·16 affected·Jun 30, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model N...
Medical Devices·4,508 affected·Jun 30, 2025
High RiskFDA
Biomerieux, Inc.
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of inst...
Diagnostic Devices·235,269 affected·Jun 26, 2025
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Medical Devices·14 affected·Jun 20, 2025
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Medical Devices·28 affected·Jun 20, 2025
High RiskFDA
Medtronic, Inc.
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application...
Medical Devices·22,091 affected·Jun 18, 2025
High RiskFDA
Medtronic, Inc.
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, ...
Medical Devices·22,091 affected·Jun 18, 2025
High RiskFDA
Fujifilm Healthcare Americas Corporation
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Optio...
Medical Devices·293 affected·Jun 11, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 So...
Medical Devices·20 affected·Jun 2, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 So...
Medical Devices·20 affected·Jun 2, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Vers...
Medical Devices·400 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Vers...
Medical Devices·200 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Vers...
Medical Devices·36 affected·May 28, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Vers...
Medical Devices·200 affected·May 28, 2025
High RiskFDA
Quantum Surgical Sas
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist i...
Medical Devices·4 affected·May 23, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Cardiology Hemodynamics Software
Medical Devices·4 affected·May 22, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Cardiology Hemo Software
Medical Devices·29 affected·May 22, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Prod...
Cardiac Devices·27,022 affected·May 14, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Descrip...
Medical Devices·847 affected·May 14, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Descript...
Medical Devices·13,240 affected·May 14, 2025
High RiskFDA
Cardinal Health 200, Llc
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Medical Devices·6,517 affected·May 13, 2025
High RiskFDA
Cardinal Health 200, Llc
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort ...
Medical Devices·6,517 affected·May 13, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: ...
Diagnostic Devices·1,958 affected·May 9, 2025
CriticalFDA
Zyno Medical Llc
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Medical Devices·613 affected·May 7, 2025
CriticalFDA
Zyno Medical Llc
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Medical Devices·613 affected·May 7, 2025
High RiskFDA
Virtual Incision Corporation
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Surgical Devices·3 affected·Apr 23, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Diagnostic Devices·231 affected·Apr 23, 2025
High RiskFDA
C-rad Positioning Ab
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Ca...
Diagnostic Devices·44 affected·Apr 22, 2025
CriticalFDA
Vyaire Medical
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Descri...
Respiratory Devices·1,895 affected·Apr 10, 2025
High RiskFDA
Tornier S.a.s.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Surgical Devices·438 affected·Apr 10, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Medical Devices·996 affected·Apr 7, 2025
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Medical Devices·4,174 affected·Apr 7, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coul...
Diagnostic Devices·0 affected·Mar 20, 2025
High RiskFDA
Spectrum Medical Ltd.
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product ...
Medical Devices·156 affected·Mar 19, 2025
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sens...
Medical Devices·264,252 affected·Mar 19, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product ...
Medical Devices·2,947 affected·Mar 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product ...
Medical Devices·19 affected·Mar 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product ...
Medical Devices·1 affected·Mar 18, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions...
Diagnostic Devices·136 affected·Mar 17, 2025
CriticalFDA
Draeger, Inc.
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Descripti...
Respiratory Devices·65,150 affected·Mar 12, 2025
CriticalFDA
Draeger, Inc.
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not app...
Medical Devices·3,140 affected·Mar 12, 2025
High RiskFDA
Carefusion 303, Inc.
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (AD...
Medical Devices·7,357 affected·Mar 11, 2025