China NMPA Product Recall - Endoscopic irrigation and suction system

Karl Storz Endoscopy (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Hysteromat E. A. S. I. endoscopic irrigation and suction system on March 4, 2021. This action stemmed from a finding by Karl Storz SE & Co. KG during a technical document review in Germany, which revealed insufficient clinical evidence to fully confirm the consistency between the device's displayed pressure value and actual intracavitary pressure. Consequently, the device could not be proven to comply with relevant regulatory requirements.

The recall is overseen by the National Medical Products Administration (NMPA) in China and impacts specific product models, specifications, and batches, detailed in a supplementary Medical Device Recall Event Report Form. The company’s proactive measure addresses this regulatory compliance gap regarding clinical evidence for pressure accuracy.

Crucially, as of the recall's publication, there were no known instances of patient injury globally, nor any related case reports in mainland China, associated with this issue. The recall highlights the company's commitment to product safety and regulatory adherence based on comprehensive clinical substantiation.