China NMPA Product Recall - Portable anesthesia laryngoscope imaging system

Karl Storz Endoscopy (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its portable anesthesia laryngoscope imaging system (Registration Certificate No.: 20152220617) on December 3, 2019. This action follows feedback received by its headquarters, Karl Storz SE & Co. KG, regarding a potential issue with the C-MAC video laryngoscope lens. The main concern is that the glass cover of the lens and/or LED light source may detach over time if the product’s cleaning, disinfection, and sterilization instructions are not strictly followed. If this damage goes unnoticed, there is a risk of the glass cover detaching during subsequent use, potentially compromising patient safety or product function. The recall is being managed under the regulatory oversight of the National Medical Products Administration (NMPA) in China, specifically documented with Index No. JGXX-2019-10812 and reported by the Shanghai Municipal Drug Administration. Specific affected product models, specifications, and batch numbers are detailed in an accompanying "Medical Device Recall Event Report Form." This proactive measure by Karl Storz aims to address the identified product safety concern and ensure compliance with regulatory standards.