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…
Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
This communication is an FDA Early Alert. 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 Abbott Diabetes Care has issued a letter to distributors, health care providers, and…
Recall Alert: Glycar SA Removes Pericardial Patch
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 The FDA is aware that Glycar SA has issued a letter to affected customers recommending…
Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue
This recall involves updating instructions for using 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 Product…
Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
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 correction. Affected Product Device Description: Streamline Bloodline…
Recall Alert: Baxter Permanently Removes Life2000 Ventilation System
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…
Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform
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…
Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices
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,…
Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi
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…
Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
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…