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
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
Medical Devices·1 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
Medical Devices·7 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
Medical Devices·2 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
Medical Devices·1 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
Medical Devices·6 affected·Jun 24, 2024
High RiskFDA
Carefusion 303, Inc.
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
Medical Devices·1 affected·Jun 24, 2024
High RiskFDA
B Braun Medical Inc
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 871303...
Medical Devices·9,943 affected·Jun 14, 2024
High RiskFDA
Qiagen Sciences Llc
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an...
Diagnostic Devices·419 affected·Jun 3, 2024
High RiskFDA
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a...
Medical Devices·1 affected·May 27, 2024
High RiskFDA
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a p...
Medical Devices·1 affected·May 27, 2024
High RiskFDA
Alcon Research Llc
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Surgical Devices·230 affected·May 23, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
Medical Devices·3 affected·May 16, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Medical Devices·1 affected·May 16, 2024
CriticalFDA
Icu Medical Inc
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, ...
Medical Devices·14,744 affected·May 7, 2024
High RiskFDA
Blue Belt Technologies, Inc
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spati...
Medical Devices·916 affected·May 7, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascu...
Cardiac Devices·391 affected·May 2, 2024
High RiskFDA
Nihon Kohden America Inc
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display...
Cardiac Devices·16 affected·Apr 29, 2024
High RiskFDA
Lucid Diagnostics, Inc.
Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Pr...
Medical Devices·220 affected·Apr 24, 2024
High RiskFDA
Lucid Diagnostics, Inc.
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Pr...
Medical Devices·157 affected·Apr 24, 2024
High RiskFDA
Philips North America Llc
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Medical Devices·358 affected·Apr 19, 2024
High RiskFDA
Tornier S.a.s.
Stryker Blueprint Software, Catalog #BPUE001.
Medical Devices·0 affected·Apr 16, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·68 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·1,635 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·40 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·20 affected·Apr 15, 2024
RecallFDA
Randox Laboratories Ltd.
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of dr...
Medical Devices·40 affected·Apr 5, 2024
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating f...
Medical Devices·705 affected·Apr 4, 2024
High RiskFDA
Corentec Co., Ltd
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Medical Devices·397 affected·Mar 29, 2024
High RiskFDA
Corentec Co., Ltd
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Medical Devices·35 affected·Mar 29, 2024
CriticalFDA
Sonarmed Inc
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Medical Devices·145 affected·Mar 25, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·9,999 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·1,002 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·775 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·789 affected·Mar 19, 2024
High RiskFDA
Electro Medical Systems Sa
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bot...
Medical Devices·462 affected·Mar 13, 2024
High RiskFDA
Electro Medical Systems Sa
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These b...
Medical Devices·54 affected·Mar 13, 2024
High RiskFDA
Advanced Instruments, Llc
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of se...
Medical Devices·58 affected·Mar 11, 2024
High RiskFDA
Philips North America
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Medical Devices·2,323 affected·Feb 28, 2024
High RiskFDA
Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Versi...
Medical Devices·257,183 affected·Feb 28, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Diagnostic Devices·628 affected·Feb 23, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Diagnostic Devices·67 affected·Feb 23, 2024
High RiskFDA
Ptw-freiburg
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data set...
Medical Devices·1 affected·Feb 8, 2024
High RiskFDA
Landauer
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000,...
Medical Devices·975 affected·Feb 8, 2024
High RiskFDA
Life Technologies Corporation
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of hu...
Medical Devices·28 affected·Feb 7, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Medical Devices·30 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Medical Devices·44 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Medical Devices·7 affected·Jan 26, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Medical Devices·142 affected·Jan 26, 2024