Medical devices recalls – page 4

• Velys Enabling Tech Robotic-Assist Station recall
  FDA September 9, 2026 · Medos International Sarl · Class II
• 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 recall
  FDA September 9, 2026 · Fresenius Medical Care Renal Therapies Group, LLC · Class II
• LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
  FDA September 9, 2026 · Boston Scientific Corporation · Class II
• LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
  FDA September 9, 2026 · Boston Scientific Corporation · Class II
• LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
  FDA September 9, 2026 · Boston Scientific Corporation · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall
  FDA September 9, 2026 · Baxter Healthcare Corporation · Class II
• Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS recall
  FDA September 9, 2026 · Baxter Healthcare Corporation · Class II
• HEALON EndoCoat PRO recall
  FDA September 9, 2026 · Johnson & Johnson Surgical Vision, Inc. · Class II
• Medline Convenience Kits: 1) BLOOD DRAW KIT recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751 recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) PRE-OP KIT recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) IV START KIT recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) ULTRASOUND BREAST PACK… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920 recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) DYKM1414 recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) CDS840396X recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT… recall
  FDA September 9, 2026 · Medline Industries, LP · Class II
• STA Staclot Protein S, Model recall
  FDA September 9, 2026 · Diagnostica Stago, Inc. · Class II
• Halyard medical convenience kits labeled as: 1) A-P PACK - 205936… recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• 1) NEURO, (kit) ACNE73-01 recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• Halyard medical convenience kits labeled as: 1) ENT… recall
  FDA September 9, 2026 · AVID Medical, Inc. · Class II
• Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231… recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327… recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332… recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• Philips Brilliance recall
  FDA September 9, 2026 · Philips North America Llc · Class II
• FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1… recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 recall
  FDA September 2, 2026 · GE Medical Systems Information Technologies Inc · Class II
• POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider… recall
  FDA September 2, 2026 · Olympus Corporation of the Americas · Class II
• ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part… recall
  FDA September 2, 2026 · IMRIS Imaging Inc · Class II
• ORT200, operating room table, including the ORT200 Covered Table Assembly… recall
  FDA September 2, 2026 · IMRIS Imaging Inc · Class II
• healthmark ProChek-W Protein Test for Robotic Arms recall
  FDA September 2, 2026 · Healthmark Industries Co., Inc. · Class II
• healthmark ProChek-II, Model Number PT-313, PT-201-12 recall
  FDA September 2, 2026 · Healthmark Industries Co., Inc. · Class II
• FUJIFILM Synapse PACS software v7.4.310 recall
  FDA September 2, 2026 · FUJIFILM Healthcare Americas Corporation · Class II
• Medline convenience kits labeled as: 1) LAMI FUSION… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II
• Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF… recall
  FDA September 2, 2026 · Medline Industries, LP · Class II