Medtronic, Abbott, Roche Among Major MedTech Firms Issuing Recalls in China; IPO Filings Reported

September 2nd - September 5th, the official website of the National Medical Products Administration was updated11 ArticlesMedical Device Product Recall Information: Several Well-Known Medical Companies Are Also Included.The specific information is as follows:

Abbott Diagnostics Medical Co., Ltd.Report: Due to the incorrect packaging of kits intended for sale only in the United States into boxes destined for Ireland, Abbott Diagnostics Technologies AS, the manufacturer based in Norway, has taken action regarding its production.Glycated Hemoglobin Assay Kit (High-Performance Liquid Microcolumn Chromatography) Afinion HbA1c（China Medical Device Registration No. 20152401837) Voluntary recall. Recall level isLevel 3 Recall。

Philips (China) Investment Co., Ltd.Report: Due to reasons such as the possible absence of safety shields on the conductors of gradient coils in a small number of products, the manufacturer Philips Medical Systems Nederland B.V., based in the Netherlands, has taken action regarding its production.Medical Magnetic Resonance Imaging System（CFDA Approval No. 2008-3281795, CFDA Approval No. 2013-3284026) Voluntary recall. Recall level isLevel 3 Recall。

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd.Report: Due to the absence of electrical safety testing in some products, the manufacturer Datex-Ohmeda, Inc. has taken action regarding the products it produced.Infant Radiant Warmer（Registration No.: 20153080683, 20153080985) Voluntary recall. Recall level isLevel 2 Recall。

Medtronic (Shanghai) Management Co., Ltd.Report: Due to reasons such as potential capacitor damage caused by dropping or collision in some products, the manufacturer Medtronic MiniMed has addressed the issue with its production.Hybrid Closed-Loop Insulin Delivery SystemHybrid Closed Loop Insulin Delivery System（China Medical Device Registration No. 20233140061) Voluntary recall. Recall level isLevel 2 Recall。

Medtronic (Shanghai) Management Co., Ltd. ReportDue to the issue of false-negative reactions in some NIM Vital nerve monitors, the manufacturer, Medtronic Xomed, Inc., an American company, has taken action regarding its production.NIM Vital Nerve Monitoring System（China Medical Device Registration No. 20233070120) Voluntary recall. Recall level isLevel 1 Recall。

Roche Diagnostics Products (Shanghai) Co., Ltd. ReportDue to calibration signal abnormalities and other issues with some creatine kinase test reagents shipped to the United States, the manufacturer Roche Diagnostics GmbH has taken action regarding its production.Creatine Kinase Assay Kit (Colorimetric Method)（China Medical Device Registration No. 20152403262) Voluntary recall. Recall level isLevel 2 Recall。

Abbott Medical Devices (Shanghai) Co., Ltd. Report, due to the possibility that some pre-sterilized implantable left ventricular assist systems' controllers may experience screen film lifting, the manufacturer Abbott Medical has addressed the issue with its production.Implantable Left Ventricular Assist System（China Medical Device Registration No. 20243120384) Voluntary recall. Recall level isLevel 2 Recall。

Shanghai AB Sciex Analytical Instrument Trading Co., Ltd. Report, due to the rare circumstances,Liquid Chromatography Tandem Mass Spectrometry System LC-MS/MS System（China Medical Device Registration No. 20232220176）Due to reasons such as the potential leakage of solvents at the top of the ion source probe, which could ultimately pose health or property risks to customers, the manufacturer AB Sciex Pte. Ltd. has voluntarily recalled the product. The recall level isLevel 2 Recall。

Cook (China) Medical Trading Co., Ltd. ReportDue to the inconsistency between the product model stated on the packaging of certain specific batches of esophageal dilators and the actual product model, the manufacturer, Wilson-Cook Medical Incorporated, has taken action regarding its production.Esophageal Dilator Savary-Gilliard Dilators（China Medical Device Registration No. 20152024227) Voluntary recall. Recall level isLevel 3 Recall。

AccuMed Medical Device (Shanghai) Co., Ltd.Report: Due to incorrect anodizing and laser marking on some products, the manufacturer Arthrex, Inc. has issued a recall for the affected products.Foot and Ankle Locking Plate SystemArthrex Fracture Plates and Screws（CN Med Device Reg Cert 20243130121) Voluntary recall. Recall level isLevel 3 Recall。

Zimmer (Shanghai) Medical International Trading Co., Ltd. ReportDue to the issue of mixed batches of different models of the Exceed ABT System hip prostheses in specific batches, the manufacturer Biomet UK Limited has taken action regarding its production.Hip Joint Prosthesis Exceed ABT System（China Medical Device Registration No. 20183131567) Voluntary recall. Recall level isLevel 3 Recall。