China NMPA Product Recall - Endotest Medical Handheld Pressure Pump

Willy Rüsch GmbH, a medical device manufacturer, has initiated a voluntary Class III recall of its Endotest medical handheld pressure pumps, specifically model 112700-000000 (National Medical Device Registration No. 20160317). This action, publicly announced on March 19, 2024, and reported by Telif Medical Devices Trading (Shanghai) Co., Ltd., stems from the product's failure to meet the required registration standards for the Taiwan market. The National Medical Products Administration (NMPA) document confirms the Class III recall level, indicating that while there is a compliance issue, the product's use is not expected to cause serious adverse health consequences. Willy Rüsch GmbH is undertaking this recall to address the regulatory non-compliance in Taiwan. Stakeholders, including distributors and healthcare professionals, are advised to refer to the "Medical Device Recall Event Attachment: Medical Device Recall Event Report Form" provided by Telif Medical Devices Trading (Shanghai) Co., Ltd. for detailed information on affected models, specifications, and batch numbers, ensuring proper management of the recalled devices.