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 Medline has issued a letter to affected customers recommending certain convenience kits be…
Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
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 The FDA is aware that Fresenius Kabi…
Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
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 The FDA is aware that Fresenius Kabi…
Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
The affected products and recommendations for what to do with the devices below have not changed. 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…
Insulin Pump Recall: Insulet Removes Omnipod Pods
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. The affected products and recommendations for what to do with the devices below have not changed. Affected…
Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
The affected products and recommendations for what to do with the devices below have not changed. 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…
Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
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. The affected products and recommendations for what to do with the devices below have not changed. Affected…
First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices
The FDA has provided recommendations for patients, caregivers, and health care providers in the “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health” FDA Safety Communication. The FDA has identified this recall as a Class I, the most serious type. This device may cause serious injury or death if you continue to…
Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and Panda Infant Resuscitation Systems and Warmers with a M1091607-R Blender
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. The affected products and recommendations for what to do…
Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers
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. The Reason for Correction…