Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope

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. Affected Product Product Name: i-View Video Laryngoscope Model Number: 8008000 Lot/Serial Numbers: 1240555 and 1240793 What to…

Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems

This recall involves correcting certain devices and does not involve removing them 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 without correction.   Affected Products Product Name  Material Number UDI-DI MAGNETOM…

Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication

Español 简体中文 (Simplified Chinese) Tagalog Update: November 13, 2025 The FDA has taken actions to address the marketing of unauthorized anti-choking devices, including issuing Warning Letters and an Import Alert. Additional information is provided below under the FDA Actions section.  Date Issued: April 22, 2024 The U.S. Food and Drug Administration (FDA) encourages the public to follow…

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

Summary Company Announcement Date: November 06, 2025 FDA Publish Date: November 07, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Out-of-specification endotoxin results Company Name: Fresenius Kabi USA, LLC Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Famotidine Injection, USP 20 mg per 2 mL Company Announcement Nov. 6,2025 – LAKE…

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Summary Company Announcement Date: October 31, 2025 FDA Publish Date: November 03, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection Company Name: Otsuka ICU Medical LLC Brand Name: Brand Name(s) ICU Medical Product Description: Product…

Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Summary Company Announcement Date: October 31, 2025 FDA Publish Date: November 03, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for endobronchial combustion Company Name: Olympus Corporation Brand Name: Brand Name(s) Product Description: Product Description Bronchofiberscopes and bronchovideoscopes Company Announcement CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced…