FDA Warning & Recall Information

The FDA has announced an urgent recall of the Defibtech RMU-2000 ARM XR Chest Compression Device due to a motor issue that could render the device inoperable. Defibtech, LLC, initiated the recall on July 12, 2024. Defibtech issued the recall after reports of one injury […]

The FDA announced on Monday, August 26th, a recall initiated by Sunco & Frenchie LLC of two lots of its 10oz Terrafina Golden Raisins due to the potential presence of undeclared sulfites. Consumption of the product could cause a serious and potentially fatal allergic reaction […]

According to the FDA, B. Braun Medical Inc. (B. Braun), of Bethlehem, Pennsylvania, has recalled two lots of its 0.9 Sodium Chloride for Injection USP 1000 mL in E3 containers because the product may contain particulate matter, and its containers may potentially leak fluid. The […]

Perrigo Company plc, of Dubin, Ireland, and Allegan, Michigan, has recalled 16,500 cans of CVS Health and H-E-B Baby-branded Premium Infant Formula with Iron Milk-Based Powder because the product was found to contain an excessive level of Vitamin D, reports the FDA. Initiated by the […]

Breas Medical has announced a nationwide correction of 8,186 Vivo 45 LS ventilator devices after internal testing determined that the product may be putting users at risk for exposure of short term heightened levels of formaldehyde, reports the FDA. Those subjected to even short-term emissions […]

According to the FDA, Edison, New Jersey-based Yummy Foods has recalled its line of Yummy Swirly Ices, marketed as non-dairy products, due to the potential presence of milk, a major allergen not listed on the ingredient list. Although officials are recalling the entire product line, […]

The FDA is warning consumers that CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps are in need of software corrections due to multiple problems that have been identified in outdated software. Initiated by Smiths Medical, the recall has been labeled in an August 6, 2024 post […]

Brooklyn, New York-based Prime Foods Processing LLC has recalled 477 cases of its Egg Custard Steamed Buns in two varieties because the products may contain sesame, a major allergen not listed on its packaging, reports the FDA. Those who live with an allergy or serious […]

According to the FDA, Baxter International Inc., of Deerfield, Illinois, has recalled lot number N008235 of its Heparin Sodium in 0.9% Sodium Chloride Injection after issues with a bacterial endotoxin test revealed a potential for elevated endotoxin levels in the batch. Consumers are warned that […]

According to the FDA, Hallandale, Florida-based North Fish USA Inc. has recalled its 9-ounce packages of imported “Cold Smoked Capelin” following a routine inspection conducted by New York State Department of Agriculture and Markets Foods Inspectors and then a later analysis by staff from Food […]

G.S. Gelato & Desserts, Inc., of Fort Walton Beach, Florida, has recalled a single lot of its Full Circle Market-branded Coconutmilk Chocolate Almond Crunch Non-Dairy Frozen Dessert because the product contains cashew, a major allergen not disclosed due to a mislabeling, reports the FDA. Consumers […]

The FDA is informing the public that Medtronic has issued a corrective recall for its NIM Vital Nerve Monitoring System after receiving reports of false negative responses. While the recall does not involve a removal of the product from places of their use or sale, […]