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…
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…
Glucose Monitor Sensor Recall: Abott 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…
Early Alert: Heart Pump Issue from Abiomed
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 an Urgent Medical Device Correction to notify affected customers of updated…
Early Alert: Insufflation Unit Issue from Olympus
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 Olympus has issued a letter to affected customers recommending certain High Flow Insufflation Units…
Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences
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 Integra LifeSciences has issued a letter to affected customers recommending all MediHoney Wound and…