# China NMPA Product Recall - Disposable mucosal incision knife; disposable endoscopic injection needle; disposable aspiration biopsy needle; disposable electric snare; disposable ligation device; transparent mucosal suction sheath; disposable mucosal incision knife; single-use high-frequency placement endoscopic active instrument; stone retrieval balloon; balloon catheter; biopsy kit and accessories; clamp device; biliary stent; lithotripter; curette; contrast tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/b035a11f-ccea-469b-b5e8-6081b740460d/
Source feed: China

> China NMPA product recall for Disposable mucosal incision knife; disposable endoscopic injection needle; disposable aspiration biopsy needle; disposable electric snare; disposable ligation device; transparent mucosal suction sheath; disposable mucosal incision knife; single-use high-frequency placement endoscopic active instrument; stone retrieval balloon; balloon catheter; biopsy kit and accessories; clamp device; biliary stent; lithotripter; curette; contrast tube by Olympus Trading (Shanghai) Co., Ltd. published December 11, 2020. Recall level: Level 2 Recall. Olympus Trading (Shanghai) Co., Ltd. initiated a Level II voluntary recall on December 11, 2020, in 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling the following products: disposable mucosal incision knives; disposable endoscopic injection needles; disposable aspiration biopsy needles; disposable electric snares; disposable ligation devices; transparent mucosal suction sleeves; disposable electric snares; disposable mucosal incision knives for single-use high-frequency placement of endoscopes; stone retrieval balloons; stone retrieval balloons; balloon catheters; balloon catheters; biopsy kits and accessories; clamp devices; biliary stents; lithotripters; curettes; contrast tubes; and disposable aspiration biopsy needles.
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-12-11
- Product Name: Disposable mucosal incision knife; disposable endoscopic injection needle; disposable aspiration biopsy needle; disposable electric snare; disposable ligation device; transparent mucosal suction sheath; disposable mucosal incision knife; single-use high-frequency placement endoscopic active instrument; stone retrieval balloon; balloon catheter; biopsy kit and accessories; clamp device; biliary stent; lithotripter; curette; contrast tube
- Recall Level: Level 2 Recall
- Recall Reason: The products in question have issues stemming from problems discovered during the production of stone-removing airbags by overseas manufacturers, including abnormal heat sealing of the aseptic packaging (partial heat seal detachment, unsealed areas).
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: Olympus Trading (Shanghai) Co., Ltd. initiated a Level II voluntary recall on December 11, 2020, in response to manufacturing problems identified by overseas manufacturers. The core issue involved abnormal heat sealing of sterile packaging, specifically partial detachment and unsealed areas, found in the production process of stone retrieval airbags. This deficiency could compromise the sterility of the medical devices. Under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, Olympus Trading (Shanghai) Co., Ltd. is recalling a comprehensive range of products. Affected items include disposable mucosal incision knives, endoscopic injection needles, aspiration biopsy needles, electric snares, ligation devices, transparent mucosal suction sleeves, stone retrieval balloons, balloon catheters, biopsy kits, clamp devices, biliary stents, lithotripters, curettes, and contrast tubes, each covered by various National Medical Device Registration Certificates. The company's required action is this voluntary recall, with specific details on affected models and batches available in a supplementary "Medical Device Recall Event Report Form."

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