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…

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…

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…

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…

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…

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…

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…

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…

June 16, 2026 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of stereotactic breast biopsy needles because of recent supplier issues. The manufacturing disruption in supply of these devices is expected to impact patient care and may require adjustments to the clinical management of patients…

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…