Johnson & Johnson
Medical Device R&D and Manufacturer
Abbott
Provider of Health Diagnostic Products and Health Diagnostic Management Solutions
By the end of March 2025, the National Medical Products Administration (NMPA) issued multiple announcements,Johnson & Johnson, Abbott, Smith & NephewMultiple multinational medical device companies, including Johnson & Johnson and Abbott, have voluntarily recalled their products, involvingYesSingle-use Magnetic Localization Cardiac Pulse Electric Field Ablation Catheter,Hip Combined Compression Interlocking Intramedullary Nail System, Implantable Left Ventricular Assist System, and 10 other products.
The specific recalled products and the scope involved are as follows:
Smith & Nephew: Hip Combined Compression Interlocking Intramedullary Nail System
Smith & Nephew Medical Trading (Shanghai) Co., Ltd. reported,Due to the reasons of compatibility issuesThe manufacturer, Smith & Nephew, Inc., based in the United States, has voluntarily recalled its TriGen InterTAN Hip Fracture Nailing System (Registration No. 20143135639). The products involved in this recall were not imported into China.
Recall Level:Level 2 Recall
Scope of application:Used for femoral fractures, severe comminuted fractures, spiral fractures, larger oblique fractures, and segmental fractures, etc.
Product models and specifications involved:716426090: TRIGEN META-TAN Combined Compression Interlocking Screw Set, 90mm/85mm (Titanium Alloy, Sterile Packaging)
Regions and Countries Involved:South Africa, United States
Conavi: Single-Use Intravascular Imaging Catheter
Kainuowei Medical Technology (Wuhan) Co., Ltd. Report,Due to the reason of catheter sheath sheddingConavi Medical Inc. voluntarily recalls its disposable intravascular imaging catheter, Novasight Hybrid Catheter (Registration No. 20233060333). The products involved in this recall were not imported into China.
Recall Level:Level 2 Recall
Scope of application:This product is used in conjunction with the intravascular imaging equipment (console model: TA-03-005) manufactured by our company, for coronary artery imaging in patients who require percutaneous coronary intervention in medical institutions. This includes intravascular ultrasound imaging (IVUS) and intravascular optical coherence tomography (OCT). The OCT imaging function of the single-use intravascular imaging catheter is suitable for coronary arteries with a diameter range of 2.0-4.0mm and is not applicable to the left main coronary artery or target vessels that have undergone previous bypass surgery.
Product models and specifications involved:TA-06-0001
Regions and Countries Involved:United States, Canada
Abbott: Implantable Left Ventricular Assist System
Abbott Medical Devices (Shanghai) Co., Ltd. reported,Due to the failure of the product's mobile power supply deviceAbbott Medical, the manufacturer, voluntarily recalled its Left Ventricular Assist System (Registration No. 20243120384 for Imported Medical Devices in China).
Recall Level:Level 2 Recall
Scope of application:This product provides mechanical support for blood circulation in adult patients with advanced, refractory left-sided heart failure. It is used as a bridge to heart transplantation or recovery of cardiac function, as well as for long-term treatment. It is intended for use in medical institutions that meet the requirements for heart transplantation and have comprehensive post-operative care capabilities. Medical staff, out-of-hospital caregivers, and patients must undergo appropriate training. Contraindicated for patients who cannot tolerate anticoagulation therapy.
Regions and Countries Involved:The United States, Japan, Australia, Europe, Latin America, Taiwan, China, Hong Kong, China, Eastern Europe, the Middle East, and Africa, etc.
Product models and specifications involved:Mobile Power Supply Device 107754
Bonmed Orthopedics: Shoulder Joint System
Zimmer (Shanghai) Medical International Trading Company reported,Due to the difficulty in installing or removing the product inserterBiomet Orthopedics, the manufacturer, voluntarily recalled its Comprehensive Shoulder System (Registration No. 20153133900 for medical devices imported into China).
Recall Level:Level 3 Recall
Scope of application:This product is used for various shoulder joint replacement indications, such as non-inflammatory degenerative osteoarthritis, rheumatoid arthritis, etc. The Comprehensive humeral stem (fracture stem, etc.) is expected to be suitable for cemented or uncemented biological fixation.
Products Involved:Model 113627, involving batch numbers 65915809, 65901697, 65909480
Regions and Countries Involved:
Core Italy: Two Artificial Heart Valves
Kexin Medical Technology (Shanghai) Co., Ltd. Report,Due to the reason that the thickness of the product's leaflet pyrolytic carbon coating may be below the specification requirementsCorcym S.r.l., the manufacturer based in Italy, is voluntarily recalling its Carbomedics Prosthetic Heart Valve (Registration No. 20163132487, imported medical device). The affected products have not been used and have been isolated and stored in the warehouse.
Recall Level:Level 1 Recall
Scope of application:This product is suitable for valve replacement therapy in patients with valve disease, valve injury, and valve dysfunction.
Regions and Countries Involved: Argentina, Chile, China, Costa Rica, Greece, Iran, Ireland, Turkey, United Kingdom, Vietnam
Product models and specifications involved:
In addition, it is alsoDue to the reason that the thickness of the product's leaflet pyrolytic carbon coating may be lower than the specification requirementsCorcym S.r.l., produced by Kexin Italy Co., Ltd., has voluntarily recalled its artificial heart valve, Optiform Prosthetic Heart Valve (Registration No.: 20163132339, imported medical device in China). The affected products were unused and have been isolated and stored in the warehouse.
Recall Level:Level 1 Recall
Scope of application:Suitable for replacing the mitral valve in patients with congenital or acquired disease, or for replacing an implanted mitral valve.
Regions and Countries Involved:China, Iran
Product models and specifications involved:
Beckman Coulter: Vitamin B12 Assay Kit (Chemiluminescence Method), Fully Automated Chemiluminescence Immunoassay Analyzer
Beckman Coulter Commerce (China) Co., Ltd. Report, due to the reasons of product non-conformance,Beckman Coulter, Inc. (USA) voluntarily recalls its Access Vitamin B12 assay kit (chemiluminescent method) (Registration No.: 20172400054). The products involved in this recall were not imported into China.
Recall Level:Level 2 Recall
Scope of application:This product is used for the in vitro quantitative determination of human serum and plasma (heparin).The level of vitamin B12.
Regions and Countries Involved:The United Kingdom, Italy, Spain, Turkey, etc.
Product models and specifications involved:2×50 Tests/Box
In addition,Due to reasons such as the product rinse turntable mixer being unable to rotate freely and subsystem communication failures, leading to delays in patient diagnosis or treatment.Beckman Coulter, Inc. (USA) voluntarily recalls its DxI 9000 Access Immunoassay Analyzer (Registration No.: GuoXieZhuJin 20242220249). The products involved in this recall were not imported into China.
Recall Level:Level 2 Recall
Scope of application:This product adopts an enzyme-linked chemiluminescence method based on alkaline phosphatase, using magnetic microparticles as the solid phase. It is used in conjunction with authorized matching reagents to quantitatively or qualitatively detect analytes in human-derived serum, plasma, whole blood, and urine samples in clinical settings, including proteins, hormones, enzymes, tumor markers, vitamins, autoantibodies, infectious diseases, and drug-related items.
Regions and Countries Involved:France, the United States, Italy, Spain, Germany, etc.
Product models and specifications involved:DxI 9000 Access Immunoassay Analyzer
CooperVision: Soft Hydrophilic Contact Lenses
CooperVision Products Trading (Shanghai) Co., Ltd. reported,Due to the incorrect cylindrical power of the product,CooperVision Inc. voluntarily recalls its Soft (hydrophilic) Contact Lens (Registration No. 20213160048). The products involved in this recall were not imported into China.
Recall Level:Level 3 Recall
Scope of Application:Suitable for phakic eyes without ocular diseases, used to correct myopia, hyperopia, and astigmatism ranging from -0.75D to -2.25D.
Regions and Countries Involved:Canada and the United States
Product models and specifications involved:Myday Toric
Johnson & Johnson Subsidiary: Single-Use Magnetic Navigation Cardiac Pulse Field Ablation Catheter
Johnson & Johnson Medical (Shanghai) Ltd. reported,Due to the higher-than-expected incidence of perioperative strokeThe manufacturer, Biosense Webster (Israel) Ltd., voluntarily recalled its disposable magnetically navigated cardiac pulse field ablation catheter, Varipulse Bi-directional Catheter (Registration No.: 20253010070). The products involved in this recall were not imported into mainland China.
Recall Level:Level 1 Recall
Scope of application:The product is used in medical institutions, in conjunction with the cardiac pulsed field ablation system (Model: D1417011L) produced by our company, for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. When used in conjunction with the electrophysiological navigation system (Model: FG-5400-00) produced by our company, it can be used for electrophysiological mapping, stimulation, and providing positional information of the catheter within the heart chambers.
Regions and Countries Involved:The United States, Canada, the United Kingdom, France, Israel, Italy, Switzerland, Germany, Japan, South Korea, Hong Kong, China, Taiwan, China, etc.
Product models and specifications involved:D1412011L
According to the regulations of the National Medical Products Administration, proactive product recalls are divided into three levels, each corresponding to different degrees of health risk——
Level 1 Recall: The use of the medical device may or has already caused serious health hazards;
Level 2 Recall: The use of the medical device may or has already caused temporary or reversible health hazards.
Level 3 Recall: The use of the medical device presents a low probability of causing harm but still requires a recall.
These recall levels are divided according to the severity of the medical device defects to ensure timely measures are taken to protect public health.
Source: National Medical Products Administration
