China NMPA Product Recall - Medical suture needle Malin suture needle

The National Medical Products Administration (NMPA) has published details regarding a voluntary recall initiated by Mani Co., Ltd., specifically for certain models and batches of its medical suture needles. The recall was reported by Mani (Beijing) Trading Co., Ltd. and announced on June 22, 2021. The central issue leading to this action is the discovery of inconsistencies between the raw materials actually incorporated into the manufacturing of the affected medical suture needles and the materials officially documented in the product's Japanese listing. This discrepancy raises concerns about adherence to product specifications and regulatory compliance. In response, Mani Co., Ltd. has proactively initiated a voluntary recall of the identified products. The NMPA has designated this as a Level III recall, which signifies that the use of or exposure to the violative product is not anticipated to cause adverse health consequences. The affected products are identifiable by registration certificate number 国械注进20182022327, with comprehensive model, specification, and batch details available in the attached Medical Device Recall Report Form. This action underscores the commitment to maintaining product integrity and regulatory standards within the medical device sector under NMPA oversight.