Class II medical devices recalls – page 31

• EDAN Product Name: Patient Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Patient Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Patient Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Patient Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Vital Signs Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Vital Signs Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Vital Signs Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Fetal & Maternal Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Fetal Monitor Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• Rifton Equipment, E-Pacer recall
  FDA January 28, 2026 · Community Products, LLC · Class II
• Rifton Equipment, Low Base TRAM. Model recall
  FDA January 28, 2026 · Community Products, LLC · Class II
• Rifton Equipment, TRAM. Model recall
  FDA January 28, 2026 · Community Products, LLC · Class II
• TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded… recall
  FDA January 28, 2026 · Sysmex America, Inc. · Class II
• The LDL-Cholesterol assay is comprised of two distinct phases recall
  FDA January 28, 2026 · Beckman Coulter Ireland, Inc. · Class II
• Ion Endoluminal System Product Name: Ion Vision Probe Bag Model recall
  FDA January 28, 2026 · Intuitive Surgical, Inc. · Class II
• MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model recall
  FDA January 28, 2026 · MicroPort Orthopedics Inc. · Class II
• VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius… recall
  FDA January 28, 2026 · Tyber Medical · Class II
• VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius… recall
  FDA January 28, 2026 · Tyber Medical · Class II
• LEASEIR Product Name: LEASEIR MHR XCELL Model recall
  FDA January 28, 2026 · Leaseir Technologies Slu · Class II
• Allwell Angioplasty Pack recall
  FDA January 28, 2026 · Merit Medical Systems, Inc. · Class II
• Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A… recall
  FDA January 28, 2026 · Merit Medical Systems, Inc. · Class II
• Merit Medical , Custom Manifold Kit recall
  FDA January 28, 2026 · Merit Medical Systems, Inc. · Class II
• Merit Medical , Custom Inflation Kit recall
  FDA January 28, 2026 · Merit Medical Systems, Inc. · Class II
• Merit Medical , Custom Waste Management Kit Vascular Tray recall
  FDA January 28, 2026 · Merit Medical Systems, Inc. · Class II
• Allwell Inflation Device, for angiographic use recall
  FDA January 28, 2026 · Merit Medical Systems, Inc. · Class II
• Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference… recall
  FDA January 28, 2026 · Merit Medical Systems, Inc. · Class II
• Mazor X robotic guidance system recall
  FDA January 28, 2026 · Mazor Robotics Ltd · Class II
• SIGMA Spectrum Infusion Pump, Model recall
  FDA January 28, 2026 · Baxter Healthcare Corporation · Class II
• ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US)… recall
  FDA January 28, 2026 · ICU Medical, Inc. · Class II
• ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US)… recall
  FDA January 28, 2026 · ICU Medical, Inc. · Class II
• ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US)… recall
  FDA January 28, 2026 · ICU Medical, Inc. · Class II
• Philips Azurion system recall
  FDA January 28, 2026 · Philips Medical Systems Nederland B.V. · Class II
• GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16… recall
  FDA January 28, 2026 · Ge Medical Systems Israel, Functional Imaging · Class II
• Tego Connector recall
  FDA January 28, 2026 · ICU Medical, Inc. · Class II
• RayStation Product Name: RayStation/RayPlan Model recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation Product Name: RayStation/RayPlan Model recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation Product Name: RayStation/RayPlan Model recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation Product Name: RayStation/RayPlan Model recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation Product Name: RayStation/RayPlan Model recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation Product Name: RayStation/RayPlan Model recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation/RayPlan recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation/RayPlan recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• RayStation/RayPlan recall
  FDA January 28, 2026 · Raysearch Laboratories Ab · Class II
• Portex Spinal Tray, Item No recall
  FDA January 21, 2026 · ICU Medical, Inc. · Class II
• Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2… recall
  FDA January 21, 2026 · ICU Medical, Inc. · Class II
• CentriMag Blood Pump recall
  FDA January 21, 2026 · Thoratec LLC · Class II
• Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090… recall
  FDA January 21, 2026 · Medtronic, Inc. · Class II
• da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073… recall
  FDA January 21, 2026 · Intuitive Surgical, Inc. · Class II
• The product is used for the evaluation of the intrinsic coagulation… recall
  FDA January 21, 2026 · Instrumentation Laboratory · Class II
• Plum Duo Infusion System, List Number 40002-04-01 recall
  FDA January 21, 2026 · ICU Medical, Inc. · Class II
• ThinPrep¿ CytoLyt¿ Solution recall
  FDA January 21, 2026 · Hologic, Inc · Class II
• Catalyst+ Product Name: Catalyst, Catalyst+ Model recall
  FDA January 21, 2026 · C-Rad Positioning Ab · 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
• Medline medical procedure convenience kits labeled as: KIT ROBOTICS… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline medical procedure convenience kits labeled as: 1) ROBOTIC recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline medical procedure convenience kits labeled as: 1) WCH… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY… recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS recall
  FDA January 21, 2026 · Medline Industries, LP · Class II
• Asserachrom HPIA. Model recall
  FDA January 21, 2026 · Diagnostica Stago, Inc. · Class II