This Early Alert communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk 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 Fresenius Kabi has…

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 LRO – Sterile Medline Convenience Kits: MAJOR PACK L-F, Model Number: DYNJ0382730O LB BASIC CUSTOM…

This recall involves correcting 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 Product Product Names: NOxBOXi Nitric Oxide Delivery System Unique…

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…

This recall involves updating instructions for using 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 following the updated instructions. Affected Products This…

This recall involves correcting 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 Product Product Names: NOxBOXi Nitric Oxide Delivery System Unique…

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…

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…

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…

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…