FDA Direct – Ask A Question
Commissioner Makary and other members of FDA leadership, as well as guests, engage in timely and frank discussions.
Related Articles
Avanos Medical Recalls Ballard Closed Suction Systems
Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.
Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits
AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.
Sheehan Brothers Vending Issues a Voluntary Recall Due to an Undeclared Sesame Allergen
Springfield, Ohio (July 8, 2025)- Sheehan Brothers Vending is recalling its Cheeseburgers, Spicy Chicken Sandwich, Italian Mini Subs, Pepperoni Pizza Sub, Chili Cheese Coney and…
Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People…
FDA Embraces Radical Transparency by Publishing Complete Response Letters
The FDA today published more than 200 decision letters, known as complete response letters (CRLs).
AI-Enabled Medical Devices
The AI-Enabled Medical Device List is a resource intended to identify AI-enabled medical devices that are authorized for marketing in the United States.
Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due to Labeling Error
Mondelēz Global LLC announced today a voluntary recall of four carton sizes of RITZ Peanut Butter Cracker Sandwiches (8-pack, 20-pack, and 40pack cartons of RITZ…
FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children
The U.S. Food and Drug Administration encourages industry leaders involved in manufacturing and distribution of infant formula, baby foods, and foods intended for children to…
