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2023 China NMPA Bluebook is here:

Twenty-three Imported Devices Recalled in Third Quarter 2023


A total of 23 imported devices issued voluntary recall notices from July to September 2023. Affected manufacturers include Medtronic, Siemens, Abbott, Covidien, Johnson & Johnson, etc. Many of these devices are not sold and used in China.

There are two Class I recalls which is the most urgent category:

  • Abbott: Implantable Spinal Cord Neurostimulation System

Recall reason: The controller cannot establish communication with the implanted pulse generator (IPG) in MRI mode

  • Covidien: Central venous catheter kit for hemodialysis

Recall reason: The silicone-based lubricant applied to the catheter tip was produced in an incorrect proportion, resulting in a thick coating that blocked the catheter tip

Complete List of Recalls July-September 2023

NMPA released the recall notices with intended use, impacted region, recall reason summary, corrective measures, etc. For more information on any devices below, please email

  • Medtronic: Avalus Bioprosthesis
  • Medtronic: Endurant II Stent Graft System
  • Medtronic: Sentrant Introducer Sheath
  • Medtronic: spinal internal fixation system
  • Medtronic: Navigation and positioning system tools
  • Medtronic: Cranial surgery positioning equipment
  • Medtronic: surgical power system
  • Medtronic: Spinal neurostimulator doctor programmable system
  • Medtronic: Patient programmer
  • Medtronic: Neuromodulation equipment program controller
  • Siemens: Diagnostic Ultrasound System
  • Siemens: Digital Radiography X-ray System
  • Siemens: Digital X-ray Radiography Fluoroscopy system
  • Siemens: X-ray diagnostic system
  • Abbott: Implantable Spinal Cord Neurostimulation System
  • ArjoHuntleigh: Electric hospital bed
  • Boston Scientific: radiofrequency ablation catheter
  • Boston Scientific: subcutaneous implantable cardioverter defibrillator
  • Covidien: Central venous catheter kit for hemodialysis
  • Covidien: Sonicision Curved Jaw Cordless Ultrasonic Dissection System
  • Edwards Lifesciences: floating catheter
  • Johnson & Johnson: intraocular lens
  • Johnson & Johnson: Synthetic absorbable surgical sutures
  • Megadyne: Medical Products       Reusable Patient Return Electrode
  • MicroVention: SOFIA Distal Access Catheter
  • Olympus: fiber uterine endoscope flexible hysteroscope
  • Smith & Nephew: Total Knee System-Zirconium Niobium Alloy Femoral Condyle
  • Smith & Nephew: Interlocking intramedullary nail system
  • St. Jude Medical: Trifecta Valve with Glide Technology
  • St. Jude Medical: bioprosthetic heart valve Trifecta Valve
  • Thermo Fisher: RapID STR System
  • Zimmer: Femoral handle

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