Recalls distributed in North Carolina – page 11

• EDAN Product Name: Central Monitoring System Model recall
  FDA January 28, 2026 · Edan Diagnostics · Class II
• EDAN Product Name: Central Monitoring System 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: 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
• 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
• 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
• Tego Connector recall
  FDA January 28, 2026 · ICU Medical, Inc. · Class II
• CentriMag Blood Pump recall
  FDA January 21, 2026 · Thoratec LLC · Class II
• da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073… recall
  FDA January 21, 2026 · Intuitive Surgical, Inc. · Class II
• Catalyst+ Product Name: Catalyst, Catalyst+ Model recall
  FDA January 21, 2026 · C-Rad Positioning Ab · 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
• FreeStyle Libre 3 Plus Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• FreeStyle Libre 3 Plus Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• FreeStyle Libre 3 Plus Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• FreeStyle Libre 3 Sensor recall
  FDA January 21, 2026 · Abbott Diabetes Care, Inc. · Class I
• Healthy Truth brand Moringa Powder recall
  FDA January 21, 2026 · Organic Living Superfoods Llc · Class I
• 1972 Banana Pudding Ice Cream, 3 GAL recall
  FDA January 21, 2026 · House Of Flavors, Inc. · Class II
• 2248 Banana Pudding Ice Cream, 3 GAL recall
  FDA January 21, 2026 · House Of Flavors, 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
• 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
• The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay… recall
  FDA January 14, 2026 · Roche Diagnostics Operations, Inc. · Class II
• Town Food Service EQ CO Inc recall
  FDA January 14, 2026 · Town Food Service Equip Co Inc · Class II
• Philips EPIQ Ultrasound Systems (various models) used in conjunction with… recall
  FDA January 7, 2026 · Philips Ultrasound, Inc · Class II
• BECKMAN COULTER BICARBONATE recall
  FDA December 31, 2025 · Beckman Coulter Ireland, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II
• Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… recall
  FDA December 31, 2025 · Zimmer, Inc. · Class II