FDA Warning & Recall Information

The FDA is calling to attention an Urgent Medical Device Removal notice sent by Getinge/Maquet to healthcare providers and facilities on May 18, 2023, which warned users against using all Quadrox Oxygenators and select Getinge/Maquet Venous Hardshell Cardiotomy Reservoirs. According to officials, the device’s “potentially […]

According to the FDA, T.W. Garner Food Company, of Winston-Salem, North Carolina, has announced a voluntary recall of 50,688 bottles of its 12 oz. Texas Pete Buffalo Wing Sauce because some of the bottles may contain soy, an allergen not declared on the product’s labeling. […]

According the FDA, a recall of certain Impella 5.5 with SmartAssist sets that was initiated by Abiomed on April 17, 2023, has since been labeled Class I, the most serious type, due to a risk of major injuries or death. Indicated to support the pumping […]

Flower Foods, Inc., headquartered in Thomasville, Georgia, has voluntarily recalled select Tastykake Chocolate Kandy Kakes because the products may contain peanuts not disclosed on packaging, according to the FDA. The mislabeling poses a risk to consumers with an allergy or severe sensitivity to peanuts. Those […]

On June 5, 2023, the FDA issued a letter to healthcare providers addressing the supply constraints of non-sterile, single-use pneumatic tourniquet cuffs impacting the U.S. During the shortage of these devices, which are used primarily in elective limb surgeries, emergencies, and trauma settings, healthcare providers […]

On May 30, 2023, Williamstown, Massachusetts-based Cricket Creek Farm, LLC announced a recall of 165 units of its Sophelise cheese and 149 pounds of its Tobasi cheese because the products may be contaminated with the microbe Listeria monocytogenes, according to the FDA. Though healthy individuals […]

Miami, Florida-based DIBE LLC has announced a recall of its 6-ounce packages of Tetas Mireya brand food popsicles in Sabor Nutella, Toddy, Ferrero, Galleta Maria, and Galleta Oreo because the products may contain a number of allergens not disclosed on packaging, reports the FDA. Consumers […]

On May 26, 2023, the FDA announced it is requiring updates to the boxed warning and other information found on the label of prescription stimulants used in the treatment of attention deficit/hyperactivity disorder (ADHD), binge-eating disorder, and narcolepsy. In an effort to ensure important safety […]

According to the FDA, Austin, Texas-based Hu Products has voluntarily recalled a single production lot of its Vanilla Crunch Dark Chocolate Bar (2.1 oz bar) because a number of packages may contain hazelnut, cashew, and/or almond that was not disclosed on product labeling. Officials did […]

The FDA has identified a Class I recall of the Seattle-Positive Airway Pressure (PAP) Plus system and breathing circuit and/or anesthesia kits by Draeger Medical due to a manufacturing error. Used in a hospital setting, the Draeger Medical Seattle PAP Plus system conveys “Bubble continuous […]

According to the FDA, Werner Gourmet Meat Snacks has issued an allergy alert and voluntarily recalled 14,682 packages of its Chile Cacahuates Japones, 5oz Value Size, because the products may contain peanut, an allergen not disclosed on packaging. The mislabeling poses a risk to consumers […]

Novis PR LLC, of San Juan, Puerto Rico, has announced a voluntarily recall of one lot (Lot D20911, expiration date 10/25) of its G-Suppress DX Pediatric Drops at the consumer level because some cartons may contain an incorrect product that is not under a Novis […]