Seven Overseas Medical Device Manufacturers Issue Voluntary Recalls of Products in China Within a Single Day

　　【Pharmaceutical Network Industry DynamicsAccording to the news on the website of the National Medical Products Administration, on August 4, seven overseas medical device manufacturers voluntarily recalled their products in China. These companies include Boston Scientific Corporation, Siemens Healthcare Diagnostics Inc., Zimmer Inc., Hoya Medical Singapore Pte. Ltd., and Trivitron Diagnostics Systems Ltd.
 

　　Seven overseas manufacturers voluntarily recalled products
 

Among them, BSC Int'l Medical Trade (Shanghai) Co., Ltd. reported that Boston Scientific Corporation initiated a Level 2 recall of the subcutaneously implanted cardioverter defibrillator (China Medical Device Registration No. 20153122410) due to temporary sensing failure.
 

Siemens Medical Systems Co., Ltd. reported that due to potential issues with a specific software version of the ACUSON Redwood system, the manufacturer Siemens Medical Solutions USA, Inc. initiated a Level 2 recall of the Diagnostic Ultrasound System (Registration No. 20203060454 for Imported Medical Devices in China).
 

HOYA GEMESIS (Ningbo) Medical Device Co., Ltd. reported that due to the use of a push method for implanting intraocular lenses, the inserter may release the artificial lens too quickly, potentially causing posterior capsule rupture. The manufacturer, HOYA Medical Singapore Pte. Ltd., is voluntarily recalling preloaded aspheric posterior chamber intraocular lenses (China Medical Device Registration No. 20163162624). The recall level is Class II.
 

Zimmer (Shanghai) Medical International Trading Co., Ltd. reported that due to labeling errors involving specific models and specific batches of products, the manufacturer Zimmer Inc. initiated a Level II recall of the Femoral Stem (Registration No. 20173130148).
 

Thermo Fisher Scientific (China) Co., Ltd. reported that due to the potential for false susceptibility results when testing Proteus species with specific antibiotics, the manufacturer, Trek Diagnostic Systems, has voluntarily recalled Streptococcus susceptibility panels (Registration No. 20182402254) and Haemophilus influenzae/Streptococcus pneumoniae susceptibility panels (Registration No. 20162400308). The recall level is classified as a Level Three recall.
 

Smith & Nephew Medical Products International Trade (Shanghai) Co., Ltd. reported that due to packaging errors in some products, the manufacturer, Smith & Nephew, Inc. of the United States, voluntarily recalled the Interlocking Intramedullary Nail System (Registration No. 20153134228 of Imported Medical Devices in China). The recall level is Level II, and the recall action does not affect China.
 

Abbott Medical Products (Shanghai) Co., Ltd. reported that due toControllerUnable to connect or establish communication with the implanted pulse generator (IPG) in MRI mode. Abbott Medical, the manufacturer of the Implantable Spinal Cord Neurostimulation System (Registration No. 20213120264, imported medical device in China), has initiated a voluntary recall. The recall level is classified as a Level III recall.
 

Stricter Industry Regulation
 

Medical devices, as products closely related to human health and life safety, are highly valued in China, and the industry is subject to strict regulation, with stringent management systems established for product registration, production, and distribution.
 

Recently, while the aforementioned overseas medical device manufacturers have proactively recalled their products in China, quality issues of medical devices produced in China have also been frequently exposed, sounding an alarm for the industry.
 

For example, on July 28 this year, the National Medical Products Administration (NMPA) announced the results of the national medical device supervision and sampling inspection in Announcement No. 34 of 2023. The NMPA organized quality supervision inspections for five categories of products, including low-pressure electric motors for dental use and patch-type medical devices (far-infrared treatment patches, magnetic therapy patches, acupoint magnetic therapy patches). A total of 12 batches (units) of products did not meet the standard requirements.
 

Regarding the products found to be non-compliant with standard regulations in the sampling inspection, the National Medical Products Administration (NMPA) has required the provincial drug administration departments where the companies are located to promptly make administrative decisions according to relevant requirements and disclose them to the public. Provincial drug regulatory authorities must urge companies to conduct risk assessments on products that fail to meet the standards, determine the recall level based on the severity of the medical device defects, proactively recall the products, and publicly disclose recall information. They should also ensure companies quickly identify the reasons for product non-conformance, develop corrective measures, and fully implement the necessary rectifications within the specified timeframe.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.