China NMPA Product Recall - ophthalmic scalpel

Shunke Medical Devices (Shanghai) Co., Ltd. initiated a Class III voluntary recall of specific ophthalmic surgical knives, as announced on November 6, 2020. This regulatory action, overseen by the National Medical Products Administration (NMPA) and reported through the Shanghai Municipal Drug Administration, addresses identified printing errors in the product label information. The recall pertains to particular models and batches, specifically Model: 72-1501 with Batch No.: AAEW296, which were imported starting in 2020. The primary issue involves inaccuracies on the product labels, which is a critical aspect of medical device regulation to ensure proper identification and safe use. While the document does not specify inspection dates, the company proactively undertook this recall to rectify the labeling discrepancies. A Class III recall typically indicates that the product defect is unlikely to cause adverse health consequences but still violates NMPA regulations and necessitates corrective measures. Shunke Medical Devices is taking the required action to remove the affected ophthalmic surgical knives, registered under Certificate No.: 国械注进20162041656, from the market to maintain regulatory compliance and ensure product integrity within the medical device sector.