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…
Preventing Accidental Apoquel Chewable Overdoses
Image The FDA has received an increasing number of reports of pets accidentally overdosing on Apoquel Chewable (oclacitinib chewable tablets), a flavored chewable medicine approved only for dogs. Accidental overdoses have been reported in both dogs and cats. However, cats are more likely than dogs to experience serious side effects if they take too much…
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…
Early Alert: Catheter Introducer Issue from Abiomed and Oscor
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. The FDA is aware that Abiomed and its manufacturing partner Oscor have issued a letter to affected customers recommending all Introducer…
Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.
Component Name Cardinal Health Part Number Aligned Medical Solutions Part Number Component Lot Number Webcol Large Alcohol Prep Pad 5110 69124 25K006462 Full List of Affected Products What to Do Apply the Aligned Medical Solutions over-label (see Recall Notice image below) to affected inventory. When the affected convenience kits are opened for use, remove, discard and do not…