# China NMPA Product Recall - Endoscopic water pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/fe195468-79ea-4029-8de3-56ce197fe00c/
Source feed: China

> China NMPA product recall for Endoscopic water pump by Olympus Trading (Shanghai) Co., Ltd. published December 30, 2021. Recall level: Level 3 Recall. Olympus Trading (Shanghai) Co., Ltd. has initiated a voluntary Level III recall of its endoscopic wa

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of endoscope water pumps.
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-12-30
- Product Name: Endoscopic water pump
- Recall Level: Level 3 Recall
- Recall Reason: The issue involves products whose production dates overlap with the validity periods of their original and renewed registration certificates, and whose Chinese instruction manuals and labels still display the original registration certificate number.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: 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."

Company: https://www.globalkeysolutions.net/companies/olympus-trading-shanghai-co-ltd/510963e8-8b01-4884-b017-bc21b376ca33/