Summary Company Announcement Date: August 25, 2025 FDA Publish Date: August 25, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Salmonella and Listeria monocytogenes contamination Company Name: Viva Raw LLC. Brand Name: Brand Name(s) Product Description: Product Description Ground Beef for Dogs and Ground Chicken for Dogs and Cats…
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics UPDATE: On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in…
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices – Letter to Health Care Providers
August 25, 2025 The U.S. Food and Drug Administration (FDA) is reminding health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices and the importance of following the manufacturer’s instructions for use. The FDA is aware of reports of serious injuries and deaths with use of HBOT devices and is…
Beaver Street Fisheries, LLC Recalls Great Value Frozen Raw Shrimp Because of Possible Health Risk
Summary Company Announcement Date: August 22, 2025 FDA Publish Date: August 22, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Possible contamination with radionuclide (Cesium-137) Company Name: Beaver Street Fisheries, LLC Brand Name: Brand Name(s) Great Value Product Description: Product Description Frozen Raw Shrimp Company Announcement Beaver Street Fisheries,…
Blue Bell Ice Cream Issues Allergy Alert on Undeclared Almond, Walnut, and Pecan in Moo-llennium Crunch Ice Cream Packaged in a Chocolate Chip Cookie Dough Half Gallon Carton with a Moo-llennium Crunch Ice Cream Lid
Summary Company Announcement Date: August 22, 2025 FDA Publish Date: August 22, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared almond, walnut, and pecan Company Name: Blue Bell Creameries, L.P. Brand Name: Brand Name(s) Product Description: Product Description Company Announcement BRENHAM, Texas, August 22, 2025 – Blue Bell Ice…
Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal
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 Product Name Lot Number UDI-DI (GTIN) CAROTID WALLSTENT MONORAIL 10.0-24 H7493915010240 08714729781097 CAROTID WALLSTENT MONORAIL…
Southwind Foods, LLC Recalls Frozen Shrimp Because of Possible Health Risk
Summary Company Announcement Date: August 21, 2025 FDA Publish Date: August 21, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination. Company Name: Southwind Foods, LLC. Brand Name: Brand Name(s) Sand Bar/Arctic Shores/Best Yet/Great American/First Street Product Description: Product Description Frozen shrimp Company Announcement…
B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter
Summary Company Announcement Date: August 19, 2025 FDA Publish Date: August 19, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the presence of particulate matter. Company Name: B. Braun Medical, Inc. Brand Name: Brand Name(s) Product Description: Product Description Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL…
Middlefield Original Cheese Co-Op Recalls 100% Grass-Fed Pepper Jack Cheese and Horseradish Flavored Cheese Due to Possible Listeria monocytogenes Contamination
Summary Company Announcement Date: August 18, 2025 FDA Publish Date: August 18, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with Listeria monocytogenes Company Name: Middlefield Original Cheese Co-op Brand Name: Brand Name(s) Middlefield Original Cheese Co-op/Copia Collective/Farmers Cheese Product Description: Product Description Company Announcement…
Early Alert: Cardiac Cannula Issue from Medtronic
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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 Medtronic has issued a…