The affected products and recommendations for what to do with the devices below have not changed. 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…
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
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 Medtronic has issued a letter to affected customers recommending certain…
Early Alert: Convenience Kits Issue from Medline
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…
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…