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
Tornier S.a.s.
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catal...
Medical Devices·20 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Ca...
Medical Devices·22 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Medical Devices·474 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Medical Devices·0 affected·Mar 5, 2025
High RiskFDA
Tornier S.a.s.
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Num...
Medical Devices·51 affected·Mar 5, 2025
High RiskFDA
Medtronic Neuromodulation
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118)...
Medical Devices·1,493 affected·Mar 4, 2025
CriticalFDA
Zoll Circulation, Inc.
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 87...
Medical Devices·91 affected·Mar 4, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Medical Devices·1 affected·Feb 28, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . ...
Medical Devices·439 affected·Feb 26, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Medical Devices·93 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Medical Devices·40 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500, Product Code 4091000
Medical Devices·1,709 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Stationary column TruSystem 7500, Product Code 1717020
Medical Devices·462 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Medical Devices·2 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Medical Devices·8 affected·Feb 25, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular info...
Medical Devices·2 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS ...
Medical Devices·11 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4....
Medical Devices·253 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular ...
Medical Devices·37 affected·Feb 19, 2025
High RiskFDA
Mim Software Inc
MIM software; System, Image Processing, Radiological
Medical Devices·352 affected·Feb 19, 2025
CriticalFDA
Carefusion 303, Inc.
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Medical Devices·0 affected·Feb 18, 2025
High RiskFDA
Brainlab Ag
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Medical Devices·0 affected·Feb 10, 2025
High RiskFDA
Medimaps Group
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1....
Medical Devices·2,036 affected·Feb 3, 2025
High RiskFDA
Leica Biosystems Nussloch Gmbh
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Medical Devices·2 affected·Jan 30, 2025
High RiskFDA
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Versi...
Medical Devices·1,850 affected·Jan 24, 2025
High RiskFDA
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product D...
Medical Devices·541 affected·Jan 24, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116...
Medical Devices·6 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3....
Medical Devices·5 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0....
Medical Devices·1 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Softwa...
Medical Devices·0 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7...
Medical Devices·0 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 ...
Medical Devices·0 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1...
Medical Devices·1 affected·Jan 16, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Softw...
Medical Devices·1 affected·Jan 16, 2025
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·64 affected·Jan 15, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the co...
Medical Devices·23 affected·Jan 10, 2025
High RiskFDA
Carefusion 303, Inc.
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog N...
Medical Devices·137,741 affected·Jan 8, 2025
High RiskFDA
Accuray Incorporated
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery Sy...
Medical Devices·212 affected·Dec 23, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (Ch...
Diagnostic Devices·1,893 affected·Dec 19, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 69...
Diagnostic Devices·3,249 affected·Dec 19, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbishe...
Diagnostic Devices·981 affected·Dec 19, 2024
High RiskFDA
Ge Medical Systems, Llc
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Soluti...
Medical Devices·7 affected·Dec 6, 2024
High RiskFDA
Quidel Ortho
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Versi...
Cardiac Devices·1,541 affected·Dec 5, 2024
High RiskFDA
A L I Technologies Ltd
Change Healthcare Cardiology Hemo software
Medical Devices·204 affected·Dec 2, 2024
High RiskFDA
A L I Technologies Ltd
McKesson Cardiology Hemo software
Medical Devices·1 affected·Dec 2, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP a...
Medical Implants·566 affected·Nov 21, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app v...
Medical Implants·59 affected·Nov 21, 2024
High RiskFDA
Abbott Medical
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which oper...
Medical Implants·7,295 affected·Nov 21, 2024