FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.
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FDA clears first contact lens with light-adaptive technology
FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light
Nine Whole Foods Market Stores Issue Voluntary Recall for Explorateur French Triple Creme Cheese Due to Possible Health Risk
Whole Foods Market is voluntarily recalling Explorateur French Triple Crème cheese from nine stores located in New Mexico, Texas, Arkansas, Illinois, Connecticut and New Jersey out of an abundance of caution. The cheese has the potential to be contaminated with Listeria monocytogenes.
Stewart’s Shops Issues Allergy Alert on Pint Chocolate Peanut Butter Cup Ice Cream
Stewart’s Shops Corp. is recalling units of Stewart’s pint Chocolate Peanut Butter Cup ice cream because they may have been packaged incorrectly with a “Chocolate” lid. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information
FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.
Club 13 Recalls Kratom Maeng Da Red Powder and Capsules Because of Possible Health Risk
Club 13 of St. Augustine, FL is recalling 15-gram, 30-gram, 90-gram, 150-gram, and 454-gram pouches, and all bulk orders of “Maeng Da Red” kratom powder; and 5-count, 25-count, 50-count, 100-count, 120-count capsule, and all bulk capsule orders of “Maeng Da Red” kratom bottles; and 5-count, 20-count, 25-count, 40-count, 50-count capsule “Maeng Da Red XS” kratom bottles because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Bob’s Red Mill Natural Foods, Inc. Voluntarily Recalls Organic Amaranth Flour (22 Oz.) Because of Possible Health Risk
Bob’s Red Mill Natural Foods is voluntarily recalling 2,099 cases of Organic Amaranth Flour (22 oz.), after recent testing revealed the presence of Salmonella in a single LOT of Organic Amaranth Flour (22 oz.) with a Sell By date of Nov. 26, 2015.
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Cut Fruit Express, Inc. Announces A Voluntary Recall of Fresh Bruschetta Mixed and Dips Because of Undeclared Soy and Milk
Cut Fruit Express, Inc. of Inver Grove Heights, Minnesota is voluntarily recalling packaged Bruschetta Mixes and Dips distributed through 4/4/2018, with Use-by Dates as listed below, since they may contain undeclared milk and soy. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Advocare Issues Allergy Alert in Select Bottles of Muscle Strength and Nighttime Recovery Product Because of Undeclared Milk Allergen on The Label
AdvoCare International has commenced a voluntary recall of two lots of Muscle Strength and four lots of Nighttime Recovery dietary supplements because they may contain undeclared milk that can elicit an allergic reaction in individuals who are sensitive to milk and milk products.
Independent Nutrition, Inc Issues Allergy Alert On Undeclared Milk in Ignite Pre-Workout Supplement Products
April 5, 2018, Independent Nutrition Inc, dba Back to Health of Eugene, Oregon is recalling certain lots of the Ignite High Endurance Pre-Workout Supplement products because it may contain undeclared milk. People who have an allergy or sever sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.