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 Erbe USA has issued a letter to affected customers recommending certain Erbe Flexible Cryprobes…
Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
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. This is an expansion of a previous recall. Affected Product The FDA is aware that Medline Industries…
Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products
The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. 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. Affected Product The FDA is aware that…
Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
The affected products below have 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. Medline Industries has issued an expansion to this recall. Affected Product…
Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems
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…
Early Alert: Heart Pump Purge Cassette 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 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…