FDA Warning & Recall Information

Abbott has announced a Class I recall of its Amplatzer Steerable Delivery Sheath because patients who undergo procedures using this device face an increased risk for air bubbles (air emboli). The FDA identified the recall as Class I, the most serious type, because the device […]

According to the FDA, a single production run of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit, produced by Braga Fresh, has been voluntarily recalled because the product may contain undeclared milk and egg. Soledad, California-based Braga Fresh initiated the recall on […]

The FDA is alerting consumers to the dangers of ultrasound medical devices manufactured by RoyalVibe Health, CellQuicken, and Well-Being Reality, all of which have not been reviewed for safety and effectiveness. The announcement, posted July 17, 2023, clarifies that because the FDA has not cleared […]

Heinen’s, based in Warrensville Heights, Ohio, has announced a voluntarily recall of its Heinen’s-branded Fresh Ground Cashew Butter because it may contain peanuts or almonds, two allergens not declared in the product’s ingredient statement. The inadequate labeling presents a risk to consumers with an allergy […]

According to the FDA, Ziyad Brothers Importing has recalled its 35.2 fluid ounce packages of Ziyad Brand Jameed Soup Starter because the product’s ingredient list does not clearly declare the presence of milk, a major allergen. The inadequate labeling presents a particular risk to consumers […]

The FDA is calling to attention a Class I recall of Quidel Triage Cardiac Panels by Quidel Cardiovascular Inc. (QuidelOrtho) because the device may produce false negative troponin results, which could potentially lead to a delayed diagnosis or a missed myocardial infarction. The recall, which […]

Betty Lou’s Inc., of McMinnville, Oregon, has announced a voluntary recall of its 1.5-ounce (42g) packages of Betty Lou’s Brand Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds because they may contain sesame, an allergen not listed in its ingredient statement. […]

A recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilators has been identified by the FDA as Class I, the most serious type, indicating that use of the products could cause serious injuries or death. Administered by healthcare professionals during patient transport, the […]

On July 6, 2023, Goshen, New York-based MilMar Food Group, LLC announced a recall of a single lot of its Spring Valley Potato Blintzes because the product may contain milk, an allergen not declared on the packaging’s ingredient statement. Consumers who suffer from an allergy […]

The FDA is calling to attention a Class I recall of NOxBOXi Nitric Oxide System by NOxBOX Ltd. because of a manifold defect that may lead to gas leaks and interrupted therapy to neonates. Initiated by the firm on May 3, 2023, the recall covers […]

Van’s International Foods, of Oakbrook Terrace, Illinois, has voluntarily recalled limited packages of Van’s Gluten Free Original Waffles because the product may contain wheat. Not only is the allergen not declared on the product’s ingredient statement, the potential presence of wheat contradicts the packaging’s “gluten […]

Mondelēz Global LLC, of East Hanover, New Jersey, has voluntarily recalled two varieties of its belVita Breakfast Sandwich because the products may contain traces of peanut, an allergen not declared on the packaging’s ingredient statement. The inadequate labeling poses a risk to consumers with an […]