# China NMPA Product Recall - Disposable bipolar high-frequency ultrasound dual-output surgical instruments

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/50817aec-1771-47c5-95e9-fac09542f020/
Source feed: China

> China NMPA product recall for Disposable bipolar high-frequency ultrasound dual-output surgical instruments by Olympus Medical Corporation published October 07, 2023. Recall level: Level 2 Recall. Olympus Medical Systems Co., Ltd., in coordination with Olympus Trading (Shanghai) Co., Ltd., has in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation is voluntarily recalling disposable bipolar high-frequency ultrasound dual-output surgical instruments.
- Company Name: Olympus Medical Corporation
- Publication Date: 2023-10-07
- Product Name: Disposable bipolar high-frequency ultrasound dual-output surgical instruments
- Recall Level: Level 2 Recall
- Recall Reason: Some of the handles provided by the supplier were substandard.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: Olympus Medical Systems Co., Ltd., in coordination with Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its disposable bipolar high-frequency ultrasonic dual-output surgical instruments. This action was officially announced by the National Medical Products Administration (NMPA) on October 7, 2023. The recall was prompted by a significant quality issue: certain handles, provided by a supplier for these instruments, were identified as being substandard. This critical manufacturing defect could potentially compromise the safety and performance of the surgical devices. A Class II recall indicates that while the probability of serious adverse health consequences is remote, the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences. To address this, Olympus is undertaking this recall to mitigate any risks associated with the defective components and maintain compliance with NMPA's regulatory standards. Detailed information on the specific models, specifications, and affected product batches is available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/olympus-medical-corporation/527e2e59-6901-42c2-a360-40be55f6edb8/