China NMPA Product Recall - Nasal mucosal nebulizer spray drug delivery device and laryngeal mucosal nebulizer spray drug delivery device

The National Medical Products Administration (NMPA) issued a notice regarding a voluntary global recall initiated by Wolfe Tory Medical, Inc. for its Nasal Nebulizer and Laryngeal Nebulizer Drug Delivery Devices (CFDA (Imported) 2013 No. 2665110 and No. 2665111). The recall, reported on November 3 and 6, 2016, and published by NMPA on December 5, 2016, addresses a critical issue where the devices may deliver a direct liquid flow instead of the intended complete nebulization. This malfunction could lead to insufficient local anesthesia, causing patient discomfort, although serious adverse health consequences are deemed unlikely. Wolfe Tory Medical Devices Trading (Shanghai) Co., Ltd., the responsible unit in China, confirmed that the affected products were neither imported into nor sold within mainland China. Consequently, no direct corrective actions are required domestically. However, the NMPA requested provincial food and drug administrations to enhance supervision and management of similar products to ensure public safety. The recall highlights the manufacturer's responsibility under regulatory frameworks to address product performance deviations impacting patient experience.