Medical devices recalls – page 60

• Pentax Medical Video Processor recall
  FDA August 27, 2025 · Pentax of America Inc · Class II
• Hamilton C6 recall
  FDA August 27, 2025 · Hamilton Medical AG · Class I
• RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense… recall
  FDA August 27, 2025 · Boston Scientific Corporation · Class I
• ENDOTAK RELIANCE G/SG with 4-SITE Connector… recall
  FDA August 27, 2025 · Boston Scientific Corporation · Class I
• ENDOTAK RELIANCE G/SG, transvenous defibrillation lead… recall
  FDA August 27, 2025 · Boston Scientific Corporation · Class I
• Zvu Anorectal Manometry Procedure Kit recall
  FDA August 20, 2025 · Diversatek Healthcare · Class III
• HemosIL LMW Heparin Controls recall
  FDA August 20, 2025 · Instrumentation Laboratory · Class II
• Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay recall
  FDA August 20, 2025 · Beckman Coulter, Inc. · Class II
• REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137… recall
  FDA August 20, 2025 · CareFusion 303, Inc. · Class III
• GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging… recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging… recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging… recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging… recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging… recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography… recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE Signa Voyager, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• GE Signa Artist, Nuclear Magnetic Resonance Imaging System recall
  FDA August 20, 2025 · GE Medical Systems, LLC · Class II
• Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model recall
  FDA August 20, 2025 · Insightra Medical Inc · Class II
• 3mensio Workstation (Vascular Fenestrated) software recall
  FDA August 20, 2025 · PIE Medical Imaging B.V. · Class II
• Custom Waste Management Kit recall
  FDA August 20, 2025 · Merit Medical Systems, Inc. · Class II
• Custom Manifold Kit recall
  FDA August 20, 2025 · Merit Medical Systems, Inc. · Class II
• Custom Tubing Kit recall
  FDA August 20, 2025 · Merit Medical Systems, Inc. · Class II
• High Pressure Tubing recall
  FDA August 20, 2025 · Merit Medical Systems, Inc. · Class II
• Bartels ELISA Legionella Urinary Antigen recall
  FDA August 20, 2025 · Trinity Biotech USA · Class II
• HeartMate Product Name: Mobile Power Unit Model recall
  FDA August 20, 2025 · Thoratec LLC · Class I
• HeartMate Product Name: Mobile Power Unit, AC Power Cord Model recall
  FDA August 20, 2025 · Thoratec LLC · Class I
• Plastic Trial Head Brown, 7 mm neck length recall
  FDA August 20, 2025 · Waldemar Link GmbH & Co. KG (Mfg Site) · Class II
• Prosthesis Head B, 28 mm, 7 mm neck length recall
  FDA August 20, 2025 · Waldemar Link GmbH & Co. KG (Mfg Site) · Class II
• Sparrow Ascent Patient Controller recall
  FDA August 20, 2025 · Spark Biomedical Inc · Class II
• EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS… recall
  FDA August 20, 2025 · Encore Medical, LP · Class II
• EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS… recall
  FDA August 20, 2025 · Encore Medical, LP · Class II
• Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner… recall
  FDA August 20, 2025 · Carefree Surgical Specialties · Class II
• Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner… recall
  FDA August 20, 2025 · Carefree Surgical Specialties · Class II
• Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner… recall
  FDA August 20, 2025 · Carefree Surgical Specialties · Class II
• Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner +… recall
  FDA August 20, 2025 · Carefree Surgical Specialties · Class II
• PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model recall
  FDA August 20, 2025 · Spineart Sa · Class II
• PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model recall
  FDA August 20, 2025 · Spineart Sa · Class II
• FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 recall
  FDA August 20, 2025 · Boston Scientific Corporation · Class II
• Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding… recall
  FDA August 20, 2025 · Boston Scientific Corporation · Class I
• DreamStation Auto recall
  FDA August 20, 2025 · Philips Respironics, Inc. · Class I
• DreamStation Auto BiPAP. Non-Continuous Ventilator recall
  FDA August 20, 2025 · Philips Respironics, Inc. · Class I
• DreamStation Auto CPAP. Non-Continuous Ventilator recall
  FDA August 20, 2025 · Philips Respironics, Inc. · Class I
• Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult recall
  FDA August 20, 2025 · Ambu · Class I
• Baxter Novum IQ Large Volume Pump, Product Code recall
  FDA August 20, 2025 · Baxter Healthcare Corporation · Class I
• Stryker SmartPump Tourniquet, disposable sterile (single use) DISP… recall
  FDA August 13, 2025 · Stryker Corporation · Class II
• One-piece Guedel airway, size 3, ISO 9.0, yellow recall
  FDA August 13, 2025 · Intersurgical Inc · Class II