China NMPA Product Recall - Nerve and muscle stimulators

Shanghai Tarisar Health Technology Co., Ltd. initiated a Class III voluntary recall of its TERESA-0 Nerve and Muscle Stimulators on April 24, 2015, as reported to the National Medical Products Administration (NMPA). The recall stemmed from a management oversight where the company failed to update product labels following a relocation and changes to its registered and production addresses, as well as its business registration and product certification. The primary issue was a discrepancy between the addresses printed on the product labels and the actual operational locations, along with other outdated registration information. This non-compliance meant the product labeling did not meet the standards outlined in the State Food and Drug Administration Order No. 6, "Regulations on the Management of Instructions and Labels for Medical Devices," and the broader "Regulations on the Supervision and Administration of Medical Devices." These violations posed a risk of user confusion regarding the product's official registration details. To address these issues, Shanghai Tarisar Health Technology Co., Ltd. issued a recall notice to its customers, collected all affected units, and provided free, compliant replacement products. The recall involved 100 units, with 62 having been sold in Mainland China.