Starwest Botanicals is voluntarily recalling Starwest Organic Celery Seed (Whole) because it has potential to be contaminated with Salmonella. The product is packaged in Mylar 1lb and 2 oz pouches. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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Category Archives: Food Safety News
FDA: Do not use ShoulderFlex Massager
The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.
FDA collaboration to monitor rare eye condition associated with cataract surgery
The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.
Consumer Alert: Undeclared Milk In Gollo Brand "Pan Dominicano (Dominican Bread)"
New York State Agriculture Commissioner Darrel J. Aubertine today alerted consumers to undeclared milk in “Pan Dominicano (Dominican Bread)”packaged and distributed by Gollo Desserts located at 349 Suydam St. in Brooklyn, NY. People who have severe sensitivity to milk may run the risk of serious or life-threatening reactions if they consume this product.
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FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies
Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.
FDA approves mechanical cardiac assist device for children with heart failure
The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found.
The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.
FDA Statement on the Institute of Medicine Report: Scientific Standards for Studies on Modified Risk Tobacco Products
Today, the Institute of Medicine released a report on the design and conduct of studies which the FDA will take into consideration in the assessment and ongoing review of modified risk tobacco products. A modified risk tobacco product is any tobacco product sold or distributed for use to lower the harm or risk of tobacco-related disease associated with other tobacco products.
Rising Moon Organics Announces a Voluntary Recall of One Code Date of Mislabeled Mediterranean Garlic & Herb Ravioli Due to Undeclared Soy Allergen
Rising Moon Organics® today issued a voluntary recall of Rising Moon Organics Mediterranean Garlic & Herb Ravioli, a frozen product, because of an incorrect back label on some packages. This mislabeling incident resulted in an undeclared allergen (Soy).
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Rhee Bros., Inc. Issues Allergy Alert on Undeclared Egg in "Assi" Brand Korean Cake (Gyeong Dan)
Rhee Bros.,Inc. of Hanover, MD, is recalling its 8 ounce packages of “ASSI” brand Korean Cake (Gyeong Dan) because they contain undeclared egg. People who have allergies to eggs, run the risk of serious life-threatening allergic reaction if they consume these products.
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FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.