Software recalls – page 2

• Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+… recall
  FDA May 20, 2026 · Dexcom, Inc. · Class II
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA May 20, 2026 · Dexcom, Inc. · Class II
• Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… recall
  FDA May 20, 2026 · Dexcom, Inc. · Class II
• Diowave Laser System recall
  FDA May 20, 2026 · Technological Medical Advancements LLC · Class II
• iLet Bionic Pancreas recall
  FDA May 6, 2026 · Beta Bionics, Inc. · Class II
• AIDBAGs are first aid kits of convenience composed of individually labeled… recall
  FDA May 6, 2026 · North American Rescue LLC. · Class I
• Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1… recall
  FDA May 6, 2026 · Boston Scientific Corporation · Class I
• Boston Scientific Pacemaker, Implantable Pulse Generator… recall
  FDA May 6, 2026 · Boston Scientific Corporation · Class I
• Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys… recall
  FDA April 29, 2026 · Foundation Medicine, Inc. · Class II
• CUSA Clarity C7000 Console, Software Version: 2.1.1.909… recall
  FDA April 29, 2026 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• Philips Spectral CT on Rails recall
  FDA April 22, 2026 · Philips Medical Systems · Class II
• Gentuity HF-OCT Imaging System Model G10-01 recall
  FDA April 22, 2026 · Gentuity, LLC · Class II
• RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 recall
  FDA April 8, 2026 · Reflexion Medical, Inc. · Class II
• MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and… recall
  FDA April 1, 2026 · Medtronic MiniMed, Inc. · Class II
• Welch Allyn, Inc recall
  FDA March 25, 2026 · Baxter Healthcare Corporation · Class II
• CHEMISTRY ANALYZER AU5800 recall
  FDA March 18, 2026 · Beckman Coulter Mishima K.K. · Class II
• DxC 700 AU recall
  FDA March 18, 2026 · Beckman Coulter Mishima K.K. · Class II
• cobas pro integrated solutions with cobas c 503 analytical units: cobas… recall
  FDA March 11, 2026 · Roche Diagnostics Operations, Inc. · Class II
• Hitachi Proton Beam Therapy recall
  FDA March 4, 2026 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Class II
• Hitachi Proton Beam Therapy System Ref: PROBEAT-FR recall
  FDA March 4, 2026 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Class II
• Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model recall
  FDA February 25, 2026 · Intuitive Surgical, Inc. · Class II
• MONARCH Platform, Bronchoscopy recall
  FDA February 25, 2026 · Auris Health, Inc · Class II
• Olympus High Flow Insufflation Unit recall
  FDA February 25, 2026 · Olympus Corporation of the Americas · Class I
• Olympus High Flow Insufflation Unit recall
  FDA February 25, 2026 · Olympus Corporation of the Americas · Class I
• Olympus High Flow Insufflation Unit recall
  FDA February 25, 2026 · Olympus Corporation of the Americas · Class I
• Focalyx Fusion recall
  FDA February 11, 2026 · Focalyx Technologies, LLC. · Class II
• NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification… recall
  FDA February 11, 2026 · Siemens Medical Solutions USA, Inc · Class II
• NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification… recall
  FDA February 11, 2026 · Siemens Medical Solutions USA, Inc · Class II
• NAEOTOM Alpha Software applications: syngo.CT Brain Quantification… recall
  FDA February 11, 2026 · Siemens Medical Solutions USA, Inc · Class II
• SOMATOM X.ceed Software applications: syngo.CT Brain Quantification… recall
  FDA February 11, 2026 · Siemens Medical Solutions USA, Inc · Class II
• MiniMed 780G Insulin Pump recall
  FDA February 11, 2026 · Medtronic MiniMed, Inc. · Class II
• CellMek SPS Sample Preparation System recall
  FDA February 11, 2026 · Beckman Coulter, Inc. · Class II
• Da Vinci Product Name: da Vinci X, Xi Surgical System… recall
  FDA February 11, 2026 · Intuitive Surgical, Inc. · Class II
• Patient Information Center iX recall
  FDA January 28, 2026 · Philips North America Llc · Class II
• Mazor X robotic guidance system recall
  FDA January 28, 2026 · Mazor Robotics Ltd · Class II
• Philips Azurion system recall
  FDA January 28, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Philips Azurion Systems with software versions R2.1.10 and R2.2.10… recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Philips Azurion Systems R3.0. Includes the following label descriptions… recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• BD Pyxis ES Enterprise Server recall
  FDA January 14, 2026 · CareFusion 303, Inc. · Class II
• LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 recall
  FDA January 14, 2026 · Siemens Medical Solutions USA, Inc · Class II
• Restore Clinician Programmer Application (CP App)… recall
  FDA December 31, 2025 · Medtronic Neuromodulation · Class II
• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety… recall
  FDA December 31, 2025 · ICU Medical, Inc. · Class II
• The Stryker CranialMask Tracker is a single-use device consisting of a… recall
  FDA December 31, 2025 · Howmedica Osteonics Corp. · Class II
• BD Pyxis MedStation ES recall
  FDA December 31, 2025 · CareFusion 303, Inc. · Class II
• Alinity ci-series System Control Module (SCM) recall
  FDA December 24, 2025 · Abbott Laboratories · Class II
• InPen App, Model/CFN Number: MMT-8061 (Android Users) recall
  FDA December 24, 2025 · Medtronic MiniMed, Inc. · Class II
• Intelerad InteleShare software, with ProViewer component recall
  FDA December 24, 2025 · DICOM Grid, Inc. · Class II
• 5008X CAREsystem +CLiC +CDX recall
  FDA December 24, 2025 · Fresenius Medical Care Holdings, Inc. · Class II
• GE HealthCare ViewPoint 6 recall
  FDA December 24, 2025 · GE Healthcare GmbH · Class II
• Ivenix Infusion System (IIS), LVP Software LVP-SW-0005… recall
  FDA December 24, 2025 · Fresenius Kabi USA, LLC · Class I
• IntelePACS - InteleConnect / TechPortal recall
  FDA December 3, 2025 · Intelerad Medical Systems Incorporated · Class II
• CareLink Clinic recall
  FDA December 3, 2025 · Medtronic MiniMed, Inc. · Class II
• DxFLEX Flow Cytometer recall
  FDA November 26, 2025 · Beckman Coulter, Inc. · Class II
• Alinity hq Analyzer Product Name: Alinity hq Analyzer Model recall
  FDA November 19, 2025 · Abbott Laboratories · Class II
• Tandem Mobi Insulin Pump: Description recall
  FDA November 12, 2025 · Tandem Diabetes Care, Inc. · Class I
• CellMek SPS Sample Preparation System recall
  FDA November 5, 2025 · Beckman Coulter, Inc. · Class II
• Sharesource Connectivity Platform for Use with Homechoice Claria Product… recall
  FDA November 5, 2025 · Vantive Us Healthcare LLC · Class II
• Model: Incisive CT for Brazil SKD recall
  FDA November 5, 2025 · Philips Medical Systems · Class II
• Model: CT 5300 recall
  FDA November 5, 2025 · Philips Medical Systems · Class II
• Model: Incisive CT recall
  FDA November 5, 2025 · Philips Medical Systems · Class II