# China NMPA Product Recall - Endoscopic irrigation and suction system

Source: https://www.globalkeysolutions.net/records/china_product_recall/carl-stosters-endoscopes-shanghai-co-ltd/0ebcc414-cc32-4b39-8707-d43aea364ee6/
Source feed: China

> China NMPA product recall for Endoscopic irrigation and suction system by Carl Stosters Endoscopes (Shanghai) Co., Ltd. published March 04, 2021. Recall level: Level 3 Recall. Karl Storz Endoscopy (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Hysteromat E

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carl Storz Endoscopy (Shanghai) Co., Ltd. is voluntarily recalling its endoscope irrigation and suction system.
- Company Name: Carl Stosters Endoscopes (Shanghai) Co., Ltd.
- Publication Date: 2021-03-04
- Product Name: Endoscopic irrigation and suction system
- Recall Level: Level 3 Recall
- Recall Reason: Currently, there is insufficient clinical evidence to fully confirm that the pressure values displayed by the Hysteromat E. A. S. I. irrigation and suction system are completely consistent with the actual intracavitary pressure. Therefore, it cannot be proven that the device complies with relevant standards.
- Discovering Company: Carl Stosters Endoscopes (Shanghai) Co., Ltd.
- Manufacturing Company: Carl Stosters Endoscopes (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/carl-stosters-endoscopes-shanghai-co-ltd/ccb32b53-9aa3-408f-aea4-76660389f9dd/