索引号 JGXX-2025-118 主题分类 监管信息 / 责令召回信息 标题 贝克曼库尔特（美国）股份有限公司 Beckman Coulter, Inc.对全自动化学发光免疫分析仪主动召回 发布日期 2025-02-25 贝克曼库尔特商贸（中国）有限公司报告，由于产品Z轴托盘夹持电机强行停止导致故障报警或患者测试结果报告延迟的原因，生产商贝克曼库尔特（美国）股份有限公司 Beckman Coulter, Inc.对其生产的全自动化学发光免疫分析仪DxI 9000 Access Immunoas…

索引号 JGXX-2025-114 主题分类 监管信息 / 责令召回信息 标题 美敦力公司Medtronic, Inc.对一次性使用心内诊断电极导管主动召回 发布日期 2025-02-25 美敦力（上海）管理有限公司报告，由于产品外盒标签存在错误的型号和批号，生产商美敦力公司Medtronic, Inc.对其生产的一次性使用心内诊断电极导管Intracardiac Diagnostic Electrode Catheters（国械注进20163070401）主动召回。召回级别为三级召回。本次召回…

[2/21/2025] FDA has determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved. Semaglutide injection products have been in shortage since 2022 due to increased demand…

[10/30/2024] FDA is warning consumers to not purchase or use Skin-Cap aerosol spray products because they may contain undisclosed steroids. This product, sold by Chemigroup France, formerly known as Cheminova Laboratories, has been found for sal…

[11/1/2024] FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics Fullerton Wellness is a facility…

[1/16/2025] FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. Health care professionals have confused these produ…

[9/18/2024] FDA is warning consumers and health care professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc., Camarillo, Calif., because it may have microbial contamination. SnoreStop Nasal Spray was previously …

索引号 JGXX-2025-117 主题分类 监管信息 / 责令召回信息 标题 奥里迪恩医疗1987有限公司Oridion Medical 1987 Ltd.对微旁流呼气末二氧化碳监测采样管主动召回 发布日期 2025-02-25 柯惠医疗器材国际贸易（上海）有限公司报告，由于采样管从患者的气管插管上断开困难的原因，生产商奥里迪恩医疗1987有限公司Oridion Medical 1987 Ltd.对其生产的微旁流呼气末二氧化碳监测采样管Microstream CO2 sampling line…

索引号 JGXX-2025-116 主题分类 监管信息 / 责令召回信息 标题 百多力股份有限公司BIOTRONIK AG对自膨式镍钛合金外周血管支架系统主动召回 发布日期 2025-02-25 百多力（北京）医疗器械有限公司报告，由于产品实物尺寸与包装标识不一致的原因，生产商百多力股份有限公司BIOTRONIK AG对其生产的自膨式镍钛合金外周血管支架系统Peripheral self-expanding Nitinol stent system（国械注进20153131894）主动召回。召回…