China NMPA Product Recall - Endoscopic water pump

Olympus Trading (Shanghai) Co., Ltd. has initiated a voluntary Level III recall of its endoscopic water pumps (Registration No.: 20172221931). This action, reported on December 30, 2021, stems from a regulatory discrepancy identified in the product's registration certificates. The primary issue concerns an overlapping validity period between the original import registration certificate (National Food and Drug Administration Import Registration No. 2013224686, valid November 4, 2013 to November 3, 2017) and the subsequent renewal registration certificate (National Medical Device Registration No. 20172221931, valid June 27, 2017 to June 26, 2022).

Specifically, products manufactured between June 27, 2017, and November 3, 2017, are affected because their production dates fall within this period of dual or unclear registration status. The recall is classified as Level III, typically indicating a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. This regulatory matter is overseen by the National Medical Products Administration (NMPA) and was reported through the Shanghai Municipal Drug Administration. Olympus Trading (Shanghai) Co., Ltd. is taking the required action of recalling the impacted medical devices. Further comprehensive details regarding the specific models, specifications, and batches involved are available in the attached "Medical Device Recall Event Report Form."