China NMPA Product Recall - Disposable mucosal incision knife; disposable endoscopic injection needle; disposable aspiration biopsy needle; disposable electric snare; disposable ligation device; transparent mucosal suction sheath; disposable mucosal incision knife; single-use high-frequency placement endoscopic active instrument; stone retrieval balloon; balloon catheter; biopsy kit and accessories; clamp device; biliary stent; lithotripter; curette; contrast tube

Olympus Trading (Shanghai) Co., Ltd. initiated a Level II voluntary recall on December 11, 2020, in response to manufacturing problems identified by overseas manufacturers. The core issue involved abnormal heat sealing of sterile packaging, specifically partial detachment and unsealed areas, found in the production process of stone retrieval airbags. This deficiency could compromise the sterility of the medical devices. Under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, Olympus Trading (Shanghai) Co., Ltd. is recalling a comprehensive range of products. Affected items include disposable mucosal incision knives, endoscopic injection needles, aspiration biopsy needles, electric snares, ligation devices, transparent mucosal suction sleeves, stone retrieval balloons, balloon catheters, biopsy kits, clamp devices, biliary stents, lithotripters, curettes, and contrast tubes, each covered by various National Medical Device Registration Certificates. The company's required action is this voluntary recall, with specific details on affected models and batches available in a supplementary "Medical Device Recall Event Report Form."