Date Issued: February 25, 2020 The U.S. Food and Drug Administration (FDA) is reminding health care providers and staff of ways to reduce the risk of cardiac surgery infection when using the LivaNova Heater-Cooler System 3T. This is an update to our safety communication issued in October 2018. As noted in the October 2018 safety…
Got a Question About Your Pet’s Health?
Español Do you have questions about the foods, drugs, and other issues involving your pet? The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) may be able to answer them. FDA regulates animal drugs, animal food (including pet food), and medical devices for animals, and conducts research that helps shape regulatory decisions, among…
Making Decisions for Your Health: Getting the Info You Need
Español When your doctor prescribes a medication for your child, do you know what the correct dosage is or how to measure it? Are you comfortable asking your doctor questions when you receive a lab report and don’t understand the results? Do you understand how to use the information on the Nutrition Facts Label on…
Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Name and Version: PneumoDart, TM-317 Product Code: NSN 6515-01-655-9514 Lot Number:190524J69 Manufacturing Dates: June 03, 2019 to September 17, 2019 Distribution Dates: June 03, 2019 to September…
Sierra Soups Issues Allergy Alert on Undeclared Gluten in “Pasta e Fagioli” Soup
Summary Company Announcement Date: February 24, 2020 FDA Publish Date: February 24, 2020 Product Type: Food & BeveragesSoupAllergens Reason for Announcement: Recall Reason Description Product contains undeclared gluten Company Name: Sierra Soups Brand Name: Brand Name(s) Sierra Soups Product Description: Product Description Pasta e Fagioli Company Announcement Sierra Soups of Fresno, Ca is recalling its…
ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Stellar Non-invasive and Invasive Ventilators Model Numbers: 100 and 150 with serial number range: 20160123307 to 22171057208 Manufacturing Dates: April 2016 to June 2017 Distribution Dates: April…
Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Catheter balloon may not deflate as intended Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Coronary dilatation catheters Company Announcement Abbott has voluntarily recalled specific lots of two catheters…
Natural Grocers Issues Recall on Dark Chocolate Almond Clusters
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Peanut clusters dark chocolate Non GMO Company Name: Dr. Praeger’s Sensible Foods, Inc. Brand Name: Brand Name(s) Natural Grocers Product Description: Product Description Almond clusters dark chocolate Non GMO Company Announcement…
Natural Grocers Issues Recall on Dark Chocolate Peanut Clusters
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared almonds Company Name: Vitamin Cottage Natural Food Markets, Inc. Brand Name: Brand Name(s) Natural Grocers Product Description: Product Description Peanut clusters dark chocolate Non GMO Company Announcement Vitamin Cottage Natural…
Moonstruck Chocolate Issues Allergy Alert on Undeclared Milk in 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate
Summary Company Announcement Date: February 21, 2020 FDA Publish Date: February 21, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Moonstruck Chocolate Co. Brand Name: Brand Name(s) Moonstruck Product Description: Product Description Praline Pecan & Ginger Element Bar in Dark Chocolate Company Announcement Moonstruck Chocolate Co. of…