China NMPA Product Recall - Disposable Blades

On November 16, 2021, Medtronic Xomed, Inc., in conjunction with its subsidiary Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class II recall for specific models and batches of its single-use blades and other related products. This action was prompted by a significant increase in customer complaints concerning product performance, specifically instances of tip breakage and issues related to wobbling or vibration during use. The affected products include various single-use blades, identified under Registration Certificate No.: 20162042506, with comprehensive details regarding models, specifications, and batch numbers documented in the official "Medical Device Recall Event Report Form." This recall is overseen by the National Medical Products Administration (NMPA) of China, which published the recall announcement. The NMPA serves as the primary regulatory authority for medical devices in China, ensuring product safety and efficacy. Medtronic Xomed, Inc.'s proactive measure to conduct this recall underscores its commitment to product quality and patient safety, addressing the reported functional deficiencies to prevent potential user risks. The Class II designation indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company is working to manage the recall process in accordance with regulatory guidelines to mitigate further risks.