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
Focalyx Technologies, Llc.
Focalyx Fusion
Medical Devices·18 affected·Dec 23, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices·2 affected·Dec 19, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices·2 affected·Dec 19, 2025
CriticalFDA
Sunmed Holdings, Llc
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applic...
Medical Devices·20,583 affected·Dec 15, 2025
High RiskFDA
Leaseir Technologies Slu
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: Th...
Surgical Devices·2 affected·Dec 15, 2025
High RiskFDA
Elekta, Inc.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description...
Medical Devices·0 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion system; Software Version Number: R3.1;
Medical Devices·228 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: ...
Medical Devices·10,466 affected·Dec 12, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product De...
Diagnostic Devices·23 affected·Dec 11, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 7222...
Medical Devices·990 affected·Dec 8, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Medical Devices·1 affected·Dec 5, 2025
High RiskFDA
Carefusion 303, Inc.
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421...
Medical Devices·2,079 affected·Dec 3, 2025
High RiskFDA
Medtronic Neuromodulation
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and o...
Medical Devices·7,123 affected·Dec 3, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RaySt...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023...
Medical Devices·119 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, R...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Descr...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1...
Medical Devices·22 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: Ray...
Medical Devices·8 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStat...
Medical Devices·10 affected·Nov 28, 2025
High RiskFDA
Icu Medical, Inc.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Medical Devices·12 affected·Nov 24, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Medical Devices·30 affected·Nov 21, 2025
High RiskFDA
Medtronic Neuromodulation
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABL...
Medical Devices·7,667 affected·Nov 20, 2025
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Mod...
Medical Devices·906 affected·Nov 18, 2025
High RiskFDA
Howmedica Osteonics Corp.
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-e...
Medical Devices·320 affected·Nov 12, 2025
High RiskFDA
Ge Healthcare Gmbh
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Medical Devices·1,221 affected·Nov 3, 2025
High RiskFDA
Philips North America Llc
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Medical Devices·6 affected·Oct 29, 2025
High RiskFDA
Philips North America Llc
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Medical Devices·2,341 affected·Oct 29, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and mater...
Medical Devices·3,721 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable...
Respiratory Devices·13,934 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS ...
Medical Devices·395 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portabl...
Respiratory Devices·12,201 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological param...
Medical Devices·1,457 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monit...
Medical Devices·379 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patien...
Respiratory Devices·342 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor c...
Medical Devices·3,141 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monito...
Respiratory Devices·11,987 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient...
Respiratory Devices·354 affected·Oct 24, 2025
High RiskFDA
Dermasensor Inc
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians o...
Diagnostic Devices·343 affected·Oct 13, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106...
Medical Implants·35,376 affected·Oct 9, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller...
Medical Implants·2,424 affected·Oct 9, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1...
Cardiac Devices·10,153 affected·Oct 1, 2025
High RiskFDA
Quest International, Inc.
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Ve...
Diagnostic Devices·0 affected·Oct 1, 2025
CriticalFDA
B Braun Medical Inc
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Vers...
Medical Devices·1,298,454 affected·Sep 30, 2025
High RiskFDA
Medistim Asa
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Sof...
Medical Devices·14 affected·Sep 26, 2025
High RiskFDA
Aesculap Inc
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Produc...
Medical Devices·26 affected·Sep 24, 2025
High RiskFDA
Aesculap Inc
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Descr...
Medical Devices·155 affected·Sep 24, 2025
High RiskFDA
Kico Knee Innovation Company
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V20...
Medical Implants·21 affected·Sep 19, 2025