China NMPA Product Recall - Disposable sterile syringes with/without needle

Becton Dickinson Medical (S) Pte. Ltd. has initiated a voluntary Class III recall of its single-use sterile syringes, including those with and without needles. This action was reported by Becton Medical Devices (Shanghai) Co., Ltd. and published on December 20, 2023. The primary reason for the recall is the significant discovery of insects present within the fluid path inside the syringe barrel, which compromises the sterility and safety of the medical devices. This serious quality issue could potentially pose health risks to users. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) in China, reflecting the regulatory framework governing medical device safety. The affected products are covered by National Medical Device Registration Certificate No. 20193141832, with comprehensive details regarding specific product models, specifications, and affected batches documented in the "Medical Device Recall Event Report Form." This voluntary recall by Becton Dickinson Medical (S) Pte. Ltd. demonstrates a commitment to addressing manufacturing deficiencies and upholding product integrity to protect public health. The company is taking necessary steps to remove the non-conforming products from circulation and ensure compliance with medical device standards.