China NMPA Product Recall - Hysteroscopic bipolar electrosurgical system (trade name: VERSAPOINT II)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting for manufacturer Ethicon, Inc., initiated a voluntary Level III recall for its Hysteroscopic Bipolar Electrosurgical System (VERSAPOINT II) on May 23, 2016. The National Medical Products Administration (NMPA) formally published this notice on July 6, 2016. The primary issue involved a discrepancy between the voltage and frequency specifications detailed on the product’s Chinese labels and instruction manuals, and the approved details in its Chinese product registration license. Specifically, the nominal voltage listed as "100-120/230V" on product materials differed from the "100-120/220-240V" specified in the CFDA (now NMPA) registration certificate. Critically, the company confirmed that this labeling inconsistency presents no risk to patient health or safety. As a result, the required actions focus on informing affected distributors and customers about the correct specifications. Physical return of the 17 affected units imported into China, including 11 already sold, is not required, reflecting the non-safety critical nature of the issue. This action underscores adherence to Chinese regulatory registration standards.