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 Merit Medical has issued a letter to affected customers…

Affected Product The FDA is aware that Cook Medical has issued a letter to affected customers recommending certain sizing catheters be removed from where they are used or sold. The affected devices are: Centimeter Sizing Catheters Aurous Centimeter Sizing Catheters Beacon Tip Centimeter Sizing Catheters The full list of affected product lots can be found here.   What…

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 AVID Medical has issued an Urgent Medical Device Recall Notification to affected customers recommending certain…

This recall involves updating instructions for using all 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…

Summary Company Announcement Date: April 08, 2026 FDA Publish Date: April 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain Lysinibacillus fusiformis, an environmental organism Company Name: Blaine Labs, Inc. Brand Name: Brand Name(s) Revitaderm, Tridergel Product Description: Product Description Antiseptic wound care gel bottles and tubes Company…

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…

The affected products and recommendations for what to do with the devices below have not changed. 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…

Summary Company Announcement Date: March 30, 2026 FDA Publish Date: April 01, 2026 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Device & Drug Safety/Unapproved Drug Company Name: Aphreseller Brand Name: Brand Name(s) Kian Pee Wan Product Description: Product Description Dietary supplement capsules marketed for treatment for gaining weight and stimulating appetite. Company…

Summary Company Announcement Date: March 24, 2026 FDA Publish Date: March 24, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. Company Name: Amneal Pharmaceuticals LLC Brand Name: Brand…

The affected products have been updated to remove a part number with no affected lots. The 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…