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。
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。
原文摘录：October 20, 2026 The U.S. Food and Drug Administration (FDA) is alerting health care providers about an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. … Additional Resources Import Alert 89-04 [10/19/2026] FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes [01/10/2023] Warning Letters Olympus Medical Systems Corporation Warning Letter [10/07/2026] Olympus Medical Systems Corporation Warning Letter (Hinode) [03/15/2023] Olympus Medical Systems Corporation Warning Letter (Hachioji-shi) [12/12/2022] Aizu Olympus Warning Letter [11/02/2022] Infections Associated with Reprocessed Duodenoscopes [06/30/2022] Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers [04/01/2021]
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。