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 Abiomed has issued a letter to affected customers recommending certain Impella Purge Cassettes and…
Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software
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. Affected Product The FDA is aware that Fresenius Kabi…
Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units
The affected products and recommendations for what to do with the devices below have not changed. 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…
Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
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 Trividia Health, Inc. has issued an Urgent Medical Device Correction to notify affected customers…
Hormone Replacement Therapies Can Help Women with Bothersome Menopausal Symptoms
Image The effects of menopause can make a woman’s daily life much harder, and therapies approved by the U.S. Food and Drug Administration can help. But too many women might not use these treatments to lessen their menopause symptoms because of the risks associated with these drugs described in the drug labels’ boxed warnings (the…
Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds
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 The FDA…
Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers
The affected products and recommendations for what to do with the devices below have not changed. 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…
Trividia Health, Inc. Initiates Labeling Correction for all TRUE METRIX® Blood Glucose Monitoring Systems
Summary Company Announcement Date: February 06, 2026 FDA Publish Date: February 06, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high…
Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
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 have not changed, but the “Full list of affected lots” has been modified for…
Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil 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 The FDA is aware that J&J MedTech and their subsidiary, CERENOVUS Inc., have issued a…