China NMPA Product Recall - Medical cotton swabs

Fujian Jian'ou Minzhi Medical and Health Products Co., Ltd. initiated a voluntary Level 1 recall for its medical cotton swabs (Registration No.: Minnan Medical Device (Registration) No. 20160005). This action followed a supervision and sampling inspection by Fujian Province authorities, which revealed discrepancies in the product's packaging labeling. The main issue was an incorrect specification, stating "10mm" instead of the officially registered and technically required "10cm," failing to conform to product technical specifications and approved samples.

Operating under the regulatory oversight of the National Medical Products Administration (NMPA), the company took immediate corrective actions. On December 17, 2018, Fujian Jian'ou Minzhi urgently notified all relevant parties to cease sales of affected medical cotton swab batches (20180327 and 20180706) and initiated the recall of all unsold products. Further preventative measures included the destruction of one million unused substandard packaging bags and the implementation of enhanced acceptance procedures for incoming packaging materials to prevent similar issues in the future. The recall report was submitted on January 16, 2019.