China NMPA Product Recall - Disposable retractable intravenous catheters (BD Insyte® Autoguard® Intravenous Catheters)

Becton Dickinson Infusion Therapy Systems, Inc. has initiated a voluntary Class II recall of its BD Insyte Autoguard Intravenous Catheters. This action, published by Becton Medical Devices (Shanghai) Co., Ltd. on July 2, 2025, through the National Medical Products Administration (NMPA), addresses critical performance issues identified in specific batches of these single-use retractable intravenous catheters. The primary concern leading to the recall is the reported malfunction where the needle retraction mechanism operates slowly or fails entirely during product use. This defect poses potential safety risks to both patients and healthcare professionals, as effective needle retraction is crucial for preventing needlestick injuries and ensuring safe medical procedures. Under the regulatory oversight of the NMPA, which granted the product National Medical Device Registration Certificate No. 20163142184, Becton Dickinson is taking proactive steps to mitigate these risks. The Class II recall designation indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The required action involves the comprehensive recall of all affected models, specifications, and batches of the BD Insyte Autoguard Intravenous Catheters. Detailed information regarding the scope of the recall is provided in an accompanying Medical Device Recall Event Report Form. This voluntary recall underscores the manufacturer's commitment to product safety and compliance with regulatory standards, aiming to protect public health by removing potentially faulty devices from circulation.