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…
Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software
This recall involves correcting devices and does not involve removing the 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 without correction. Affected Product Product Name: Dexcom G6 Continuous Glucose…
Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels
Summary Company Announcement Date: December 22, 2025 FDA Publish Date: December 22, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated levels of lead Company Name: Handelnine Global Limited d/b/a Navafresh Brand Name: Brand Name(s) Product Description: Product Description Rheumacare Capsules Company Announcement Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers…
Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter
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 Medtronic has issued a letter to affected customers recommending certain…
Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods
Summary Company Announcement Date: December 26, 2025 FDA Publish Date: December 26, 2025 Product Type: Animal & VeterinaryCosmeticsDietary SupplementsDrugsFood & BeveragesMedical Devices Foodborne Illness Reason for Announcement: Recall Reason Description Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process. Company Name: Gold Star Distribution, Inc. Brand Name: Brand…
Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts
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 Draeger has issued a letter to affected customers recommending certain…
Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft
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 Cook Medical has issued a letter to affected customers recommending…
Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
The FDA has become aware 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 certain Codman Microsensor Basic Kits and Cerelink ICP Sensor…
Consumers Supply Distributing, LLC Recalls Country Vet Biscuits for Dogs Due to Possible Salmonella Health Risk
Summary Company Announcement Date: December 24, 2025 FDA Publish Date: December 24, 2025 Product Type: Animal & VeterinaryFood & Beverages Pet Food Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Consumers Supply Distributing, LLC Brand Name: Brand Name(s) Country Vet, Heartland Harvest Product Description: Product Description Dog…
MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
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 Products Product Name Material Number UDI-DI MAGNETOM…