Class II medical devices recalls – page 32

• PALACOS Product Name: PALACOS MV pro 40 recall
  FDA January 21, 2026 · Heraeus Medical GmbH (Dental Division) · Class II
• PALACOS Product Name: PALACOS MV+G pro 40 recall
  FDA January 21, 2026 · Heraeus Medical GmbH (Dental Division) · Class II
• PALACOS Product Name: PALACOS R+G pro 40 recall
  FDA January 21, 2026 · Heraeus Medical GmbH (Dental Division) · Class II
• PALACOS Product Name: PALACOS R pro 40 recall
  FDA January 21, 2026 · Heraeus Medical GmbH (Dental Division) · 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
• MOSAIQ Oncology Information System with Particle Therapy License (License… recall
  FDA January 21, 2026 · Elekta, Inc. · Class II
• Allura Xper FD20/20 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD20/10 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD20 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10/10 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD20 OR Table recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD20 Biplane recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD20 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10/10 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD20 Biplane recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD20 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10/10 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10 recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10F recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• Allura Xper FD10C recall
  FDA January 21, 2026 · Philips Medical Systems Nederland B.V. · Class II
• BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated… recall
  FDA January 21, 2026 · Hangzhou Bever Medical Devices CO., Ltd. · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline Kits containing B. Braun IV Administration Sets and Pump… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 recall
  FDA January 21, 2026 · Fresenius Kabi USA, LLC · Class II
• MAXXUS, System, Tomography, Computed, Emission recall
  FDA January 21, 2026 · Ge Medical Systems Israel, Functional Imaging · Class II
• SMV BodyTrack, System, Tomography, Computed, Emission recall
  FDA January 21, 2026 · Ge Medical Systems Israel, Functional Imaging · Class II
• SMV DSI, System, Tomography, Computed, Emission recall
  FDA January 21, 2026 · Ge Medical Systems Israel, Functional Imaging · Class II
• SMV DSX New Line, System, Tomography, Computed, Emission recall
  FDA January 21, 2026 · Ge Medical Systems Israel, Functional Imaging · Class II
• A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465… recall
  FDA January 21, 2026 · Medtronic Neuromodulation · Class II
• Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F… recall
  FDA January 21, 2026 · Boston Scientific Corporation · Class II
• Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography… recall
  FDA January 21, 2026 · Mobius Imaging, LLC · Class II
• Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography… recall
  FDA January 21, 2026 · Mobius Imaging, LLC · Class II
• Medicrea, IB3D PL Instruments Set, Rx Only recall
  FDA January 21, 2026 · Medicrea International · Class II
• Medicrea, IB3D Universal Implant Inserter, Rx Only recall
  FDA January 21, 2026 · Medicrea International · Class II
• MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of… recall
  FDA January 21, 2026 · Repligen Corporation · Class II
• VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 recall
  FDA January 21, 2026 · Canon Medical System, USA, INC. · Class II
• VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 recall
  FDA January 21, 2026 · Canon Medical System, USA, INC. · Class II
• Codman CereLink ICP Sensor Basic Kit recall
  FDA January 14, 2026 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• Codman Microsensor Basic Kit recall
  FDA January 14, 2026 · Integra LifeSciences Corp. (NeuroSciences) · Class II
• Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE… recall
  FDA January 14, 2026 · Medline Industries, LP · Class II
• HFD100 Product Name: Head Fixation Device HFD100 Model recall
  FDA January 14, 2026 · IMRIS Imaging Inc · Class II
• Philips Smart-hopping 2.0 AP 1.4 GHz recall
  FDA January 14, 2026 · Philips North America Llc · Class II
• Arial 900 MHz Call Station, Model Number CSK200-900MR… recall
  FDA January 14, 2026 · Securitas Healthcare LLC · Class II
• Arial 900 MHz Call Station, Model Number CSK200-900… recall
  FDA January 14, 2026 · Securitas Healthcare LLC · Class II
• Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU recall
  FDA January 14, 2026 · Abiomed, Inc. · Class II
• The Pressio 2 ICP Monitoring System, Model Number PSO-4000 recall
  FDA January 14, 2026 · Sophysa · Class II
• BD Pyxis ES Enterprise Server recall
  FDA January 14, 2026 · CareFusion 303, Inc. · Class II
• Philips Tempus Pro Patient Monitor recall
  FDA January 14, 2026 · Remote Diagnostic Technologies Ltd. · Class II