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…
Fromi USA Recalls Brie Royal Faucon 1kg Because of Possible Health Risk
Summary Company Announcement Date: August 14, 2025 FDA Publish Date: August 14, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential contamination with Listeria monocytogenes Company Name: Fromi USA Brand Name: Brand Name(s) Brie Royal Faucon Product Description: Product Description Brie Royal Faucon Cheese Company Announcement FROMI USA of New York,…
Understanding FDA Terms for Possible New Therapies to Prevent and Treat Diseases
Image The U.S. Food and Drug Administration is responsible for protecting the public health by, among other things, ensuring the safety and effectiveness of drugs, biological products and medical devices. In certain circumstances, the FDA allows the emergency use of medical products that do not yet have agency approval. The language used to describe potential…
Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.
Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand Name: Brand Name(s) Max Mobility/Permobil Product Description: Product Description Speed Control Dial Component Company Announcement Max Mobility/Permobil has voluntarily…
Quesito El Establo Retira Del Mercado Queso (Quesito Colombiano) Debido a Posible Riesgo Para La Salud
Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 13, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Due to the presence of rodent, rodent activity, and other insanitary conditions during the manufacturing and storage process Company Name: Quesito El Establo Brand Name: Brand Name(s)…
Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
Summary Company Announcement Date: August 07, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery Company Name: Tandem Diabetes Care, Inc. Brand Name: Brand Name(s) Tandem Diabetes Care, Inc. Product Description: Product…