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Two Class I Recalls Announced in December


NMPA announced 25 recalls in December 2019, including two Class I recalls.

Class I recall (the most serious):

  • Johnson & Johnson: Multiaxial pedicle fixation system
  • Boston Scientific: Guiding catheter

Class II and Class III recall:

  • Boston Scientific: Pelvic floor repair system
  • Boston Scientific: Self-expanding stent system
  • Gore: Hydrophilic coating guide sheath
  • Gore: Thoracic aorta stent endovascular stent system
  • Biocomposites: Absorbable artificial bone powder
  • Biocomposites: Calcium sulfate
  • Maquest: Heart-lung machine-heat exchange water tank
  • Maquest: Integrated membrane oxygenator
  • Siemens: High sensitivity C reactive protein calibrator
  • Philips: X-ray computer tomography equipment
  • Roche: Automatic biochemical immunology analyzer
  • Smith & Nephew: Bone needle
  • Zimmer: Hip surgery kit
  • Beckman Coulter: Fully automatic slide dyeing system
  • Howmedica Osteonics: Hip joint prosthesis-polyethylene liner
  • Datex-Ohmeda: Infant incubator
  • Kawasumi Laboratories: Hollow fiber dialyzer
  • Ortho Clinical Diagnostics: Phenytoin reagent kit
  • Diasorin: Cardiopulmonary circulation centrifugal pump
  • Covidien: Arc staple cartridge for disposable cutting stapler under endoscope
  • Instrumentation Laboratory: Prothrombin time and fibrinogen assay kit
  • Stryker Instruments: High vacuum bone cement mixer
  • Biotronik: Self-expanding nickel-titanium alloy peripheral vascular stent system

For causes and model numbers of the recalls in November, please email

For Decree 29 Measures for the Administration of Medical Device Recall, please email us also. We charge nominal fees for the translation.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC ( provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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