Class I medical devices recalls – page 11

• Medtronic Pipeline Vantage Embolization Device with Shield Technology recall
  FDA March 12, 2025 · Micro Therapeutics, Inc. · Class I
• Medtronic Pipeline Vantage Embolization Device with Shield Technology recall
  FDA March 12, 2025 · Micro Therapeutics, Inc. · Class I
• Rotarex Atherectomy System and Instructions for Use… recall
  FDA March 12, 2025 · Bard Peripheral Vascular Inc · Class I
• VARIPULSE Bi-Directional Ablation Catheter recall
  FDA March 12, 2025 · Biosense Webster, Inc. · Class I
• VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) recall
  FDA March 5, 2025 · Ventec Life Systems, Inc. · Class I
• Cardio Vascular-Allura Centron recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 7 M20 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 7 M12 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 7 B20 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 7 B12 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 5 M20 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 5 M12 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 3 M15 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Azurion 3 M12 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD10C recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura CV20 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD20/20 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD20/15 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD20/10 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD20 OR Table recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD20 Biplane OR Table recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD20 Biplane recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD20 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD10/10 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Allura Xper FD10 recall
  FDA February 26, 2025 · Philips Medical Systems Nederland B.V. · Class I
• Intact Vascular Tack Endovascular System, to treat vascular dissections… recall
  FDA February 26, 2025 · Spectranetics Corporation · Class I
• Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use… recall
  FDA February 19, 2025 · Max Mobility LLC · Class I
• Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use… recall
  FDA February 19, 2025 · Max Mobility LLC · Class I
• Vaporizer Sevoflurane, Quik-Fil recall
  FDA February 19, 2025 · Getinge Usa Sales Inc · Class I
• Olympus Single Use Guide Sheath Kits with the following product… recall
  FDA February 19, 2025 · Olympus Corporation of the Americas · Class I
• regard Item Number: 830106006, LD01114F - Newborn Kit containing the… recall
  FDA February 12, 2025 · ROi CPS LLC · Class I
• Ivenix Infusion System (IIS), LVP Software LVP-SW-0005… recall
  FDA February 12, 2025 · Fresenius Kabi USA, LLC · Class I
• Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY… recall
  FDA February 5, 2025 · Medline Industries, LP · Class I
• Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT… recall
  FDA February 5, 2025 · Medline Industries, LP · Class I
• VDR4 Phasitron Breathing Circuit Models that contain the venturi… recall
  FDA January 29, 2025 · Percussionaire Corporation · Class I
• Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type) recall
  FDA January 22, 2025 · Olympus Corporation of the Americas · Class I
• Breathe Technologies, Inc., Life2000 Ventilation System recall
  FDA January 22, 2025 · Baxter Healthcare Corporation · Class I
• Welch Allyn, Inc., Life2000 Ventilation System recall
  FDA January 22, 2025 · Baxter Healthcare Corporation · Class I
• Welch Allyn, Inc., Life2000 Ventilation System recall
  FDA January 22, 2025 · Baxter Healthcare Corporation · Class I
• Welch Allyn, Inc., Life 2000 Ventilation System recall
  FDA January 22, 2025 · Baxter Healthcare Corporation · Class I
• nuwellis AquaFlexFlow UF 500 Plus recall
  FDA January 22, 2025 · Nuwellis Inc · Class I
• Impella RP Flex with SmartAssist recall
  FDA January 22, 2025 · Abiomed, Inc. · Class I
• Impella RP with SmartAssist recall
  FDA January 22, 2025 · Abiomed, Inc. · Class I
• VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number… recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111)… recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• PROPONENT DR Pacemaker, SL (Model Number L201)… recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311)… recall
  FDA January 22, 2025 · Boston Scientific Corporation · Class I
• Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support… recall
  FDA January 22, 2025 · Mercury Medical · Class I
• Medline Fluid Delivery Set with Drip Chamber: 1)… recall
  FDA January 22, 2025 · Medline Industries, LP · Class I
• Medline Fluid Delivery Set with Drip Chamber: 1)… recall
  FDA January 22, 2025 · Medline Industries, LP · Class I
• Sheath, 18 Fr., 160 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• Sheath, 18 Fr., 130 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• Sheath, 20 Fr., 160 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• Sheath, 20 Fr., 130 mm ( recall
  FDA January 22, 2025 · Trokamed GmbH · Class I
• JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L recall
  FDA January 15, 2025 · Jiangsu Jumao X-Care Medical Equipment CO Ltd · Class I
• Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall
  FDA January 15, 2025 · Fresenius Kabi USA, LLC · Class I
• Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System recall
  FDA January 15, 2025 · Maquet Cardiovascular, LLC · Class I
• VasoView HemoPro 2 Endoscopic Vessel Harvesting System recall
  FDA January 15, 2025 · Maquet Cardiovascular, LLC · Class I