China NMPA Product Recall - LED light curing machine

Coltène/Whaledent Inc. initiated a voluntary Class III recall of its LED curing machines (National Medical Device Registration Certificate 20162554290) in response to findings from a national random inspection. The recall, reported by Coltène/Whaledent Dental Trading (Beijing) Co., Ltd. on January 16, 2019, and published by the National Medical Products Administration (NMPA) on January 17, 2019, stems from a critical compliance issue: the charging base for the devices failed to meet safety standards due to excessive leakage current.

Upon receiving the non-compliance report, the company conducted a thorough self-inspection. This internal review confirmed that for the specific affected batch number, 180309217, there were no units in inventory and no sales had occurred within China. As a corrective action, Coltène/Whaledent provided immediate feedback to the manufacturing facility to implement stricter controls over product release, ensuring that all future outgoing products adhere to the required safety and quality specifications. This proactive measure aims to prevent similar non-compliance issues from reaching the market.