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: Life2000 Ventilation System Product Code UDI-DI Number Product Code on Shipping Carton Product…

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 Products Product Names: MEGA Ballast Distal Access Platform (originally cleared as Next Generation Access Platform)  Model…

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: SpeedControl Dial used with SmartDrive MX2+ Power Assist Device Part Numbers: MX2-3DCK, MX2-3DC,…

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…