China NMPA Product Recall - Heated disposable breathing circuit

On July 31, 2025, Draegerwerk AG & Co. KGaA, the manufacturer, initiated a voluntary Class II recall for its Heated Disposable Breathing Circuits. This action was formally reported by Draeger Medical Devices (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA). The primary reason for this recall is the identification of potential manufacturing defects within certain batches of these critical medical devices. The affected products are registered under National Medical Device Registration Certificate No. 20172086903.

It is important to note that, despite being reported through the NMPA, the specific products subject to this recall were not imported into the Chinese market. This voluntary recall demonstrates Draegerwerk AG & Co. KGaA's commitment to maintaining high product safety and quality standards across its global operations. Such proactive measures are integral to effective post-market surveillance, ensuring that potential risks are addressed promptly to safeguard patient well-being worldwide. Comprehensive details concerning the precise models, specifications, and implicated batch numbers are available in the 'Medical Device Recall Event Report Form' provided by the NMPA, underscoring the manufacturer's responsible oversight of its medical devices.