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
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
原文摘录:This recall involves implementing additional recommendations on the use of the StatStrip Glucose Hospital Meter System while awaiting a software update. … 10/20/2026 The FDA issued a communication notifying the public of a Class I Recall
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
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
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]
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