China NMPA Product Recall - Rigid fiber mammoscope

Schoelly Fiberoptic GmbH, supported by Schoelly (Guangzhou) Endoscopy Technology Co., Ltd., has initiated a voluntary recall of its rigid fiber mammoscope, specifically batch number 202204. This action followed an internal inspection which identified that the distributed medical devices had incomplete components. The product's registration certificate explicitly states that the device comprises an endoscope, a sheath, and an operating handle; however, units from the affected batch were found to be missing the operating handle. Although the operating handle's purpose is to shorten the ductoscope's length, Schoelly Fiberoptic GmbH has affirmed that its absence does not impact the overall safety or effectiveness of the product, and no patient injuries have been reported. This recall is being managed under the regulatory framework of the National Medical Products Administration (NMPA), with detailed information on affected models and specifications provided in a Medical Device Recall Event Report Form. The company is taking these required actions to ensure adherence to regulatory standards concerning product completeness.