官方与证据源
FDA 药品申请、补充申请、标签、器械与药品安全预警；AP、首次批准和召回分别理解。
5 条精选近 30 天 5 条共收录 9 条
FDA CDRH发布早期预警，通报潜在高风险器械问题：Compact Medical对部分批次ButterflyBVM一次性球囊面罩（BVM）复苏器发出紧急医疗器械召回通知，建议移除000109–000117批次，000081–000108批次须每次使用前完成使用前测试。
关注理由：FDA CDRH以Early Alert标记该潜在高风险器械问题，区分需移除批次与仅需使用前测试的批次，可据此跟踪急救通气器械的受影响范围与后续监管更新。
FDA 于2026年10月30日发布安全通告，多起报告称1.5–2.5岁幼儿食用 Once Upon a Farm Tractor Wheels 有机幼儿软烤棒后发生完全气道阻塞、无法呼吸，建议消费者勿购买或喂食并立即丢弃。
关注理由：FDA 报告多名1.5–2.5岁幼儿食用该软烤棒后发生常规急救难以解除的完全气道阻塞，且产品经全美主要零售渠道销售，属需持续跟踪更新的母婴食品安全预警。
原文摘录：CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that B. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由：这条肾脏病学资料适合作为深入阅读入口，尤其要关注研究方法与结论是否匹配。
原文摘录：This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由：这篇血液病学资料可用于了解领域进展，研究设计、结果和局限性值得一起阅读。
原文摘录：CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. … Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program
关注理由：这条呼吸病学内容涉及相关临床或研究问题，建议查看原文中的方法与适用范围。