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
Foundation Medicine, Inc.
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tr...
Medical Devices·10 affected·Mar 24, 2026
High RiskFDA
Hologic, Inc
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Softwa...
Diagnostic Devices·1,200 affected·Mar 23, 2026
High RiskFDA
Gentuity, Llc
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Medical Devices·184 affected·Mar 23, 2026
High RiskFDA
Advanced Bionics, Llc
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-...
Medical Implants·45,173 affected·Mar 23, 2026
CriticalFDA
Boston Scientific Corporation
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL M...
Cardiac Devices·685,776 affected·Mar 19, 2026
CriticalFDA
Boston Scientific Corporation
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO ...
Medical Implants·718,456 affected·Mar 19, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in co...
Medical Devices·1,033 affected·Mar 19, 2026
High RiskFDA
Beta Bionics, Inc.
iLet Bionic Pancreas, REF: BB1001
Medical Devices·1,080 affected·Mar 12, 2026
High RiskFDA
Philips Medical Systems
Philips Spectral CT on Rails. Model Number: 728334.
Medical Devices·3 affected·Mar 7, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
High RiskFDA
Clariance-sas
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3...
Medical Implants·511 affected·Feb 20, 2026
High RiskFDA
Reflexion Medical, Inc.
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Medical Devices·12 affected·Feb 9, 2026
High RiskFDA
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Medical Devices·1 affected·Feb 6, 2026
High RiskFDA
B Braun Medical Inc
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A devi...
Medical Implants·51,300 affected·Feb 2, 2026
High RiskFDA
B Braun Medical Inc
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Descrip...
Medical Implants·21,000 affected·Feb 2, 2026
High RiskFDA
Medtronic Minimed, Inc.
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Medical Devices·26,851 affected·Jan 30, 2026
High RiskFDA
Covidien Llc
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI ...
Diagnostic Devices·78 affected·Jan 30, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·1,979 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X,...
Medical Devices·5,136 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·655 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·326 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1...
Medical Devices·802 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·291 affected·Jan 26, 2026
High RiskFDA
Datascope Corp.
CS300 IABP. Software Version CS300 IABP C.01.
Medical Devices·10,897 affected·Jan 23, 2026
High RiskFDA
Datascope Corp.
CS100 IABP. Software Version CS100 IABP Q.01.
Medical Devices·10,897 affected·Jan 23, 2026
High RiskFDA
Aesculap Inc
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product...
Medical Devices·126 affected·Jan 15, 2026
High RiskFDA
Baxter Healthcare Corporation
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion...
Medical Devices·5 affected·Jan 13, 2026
High RiskFDA
Medartis Ag
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable....
Medical Devices·0 affected·Jan 9, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: The...
Medical Devices·33,433 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: The...
Medical Devices·136,037 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Pro...
Medical Devices·1,474 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Pro...
Medical Devices·10,008 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: The...
Medical Devices·30,489 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Pr...
Medical Devices·4,183 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Pr...
Medical Devices·72,023 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Prod...
Medical Devices·93 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: The...
Medical Devices·86,303 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Pro...
Medical Devices·5,946 affected·Jan 7, 2026
High RiskFDA
Olympus Corporation Of The Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Pro...
Medical Devices·10,257 affected·Jan 7, 2026
CriticalFDA
Whill, Inc.
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-whee...
Medical Devices·4,685 affected·Dec 29, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Medical Devices·41 affected·Dec 29, 2025
CriticalFDA
Whill, Inc.
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel dri...
Medical Devices·2,324 affected·Dec 29, 2025
High RiskFDA
Zimmer Surgical Inc
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Versi...
Medical Devices·51 affected·Dec 24, 2025
High RiskFDA
Zimmer Surgical Inc
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Versi...
Medical Devices·206 affected·Dec 24, 2025