Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.
Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.
Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.
Ultrasound gel manufactured by Eco-Med Pharmaceutical and distributed with various medical device kits may contain bacterial contamination. Users should stop using affected products and follow FDA guidance.
Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.
AMIVAS (US), LLC is recalling Artesunate for Injection (110 mg/vial) because an air filter failed post-integrity testing, creating a lack of sterility assurance for the product.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA has issued a Class I recall affecting 8,702 units distributed worldwide.
Terry and Joe Baker Farms is recalling 16 oz packages of kale sold under the Baker Farms, Kroger, and SEG Grocers brand names due to Listeria monocytogenes contamination detected during testing.
Earle of Sandwiches X-Large Roast Beef Italiano sandwiches may contain undeclared egg. The recall affects sandwiches purchased before September 15, 2021, distributed in Minnesota, Utah, and Washington.
ALPHA MALE+ Male Enhancer fruit chew strips are being recalled because they contain tadalafil and were marketed without FDA approval. Consumers should stop using the product and consult a healthcare provider if they have questions.
Azurity Pharmaceuticals is recalling 2,751 kits of Firvanq (vancomycin hydrochloride for oral solution) distributed nationwide because an incorrect diluent component was included in the kit.
Ford is recalling one 2021 Escape hybrid because the high voltage battery may fail, resulting in sudden loss of drive power and increased crash risk.
The Occupant Restraint Controller software in certain 2021-2022 Jeep models may be faulty, allowing airbags to disable without warning. This increases crash injury risk.
Maserati is recalling certain 2021-2022 model-year vehicles due to a defective fuel line sensor housing that may crack and leak fuel. The leak can cause engine stall or fire, increasing crash risk.
Nissan is recalling 2022 Pathfinder vehicles due to insufficient welds on the secondary hood latch bracket. The bracket may detach, allowing the hood to open if the primary latch fails, obstructing the driver's view and increasing crash risk.
Polaris is recalling certain 2020-2021 Slingshot vehicles because rear wheel studs may not have been fully pressed into the axle, risking wheel detachment and crashes. Dealers will inspect and replace the affected parts free of charge.
IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.
Medina Baking and Powder Products, Inc. is recalling Vanilla Flavor Imitation (White) in 128 fl. oz. gallons due to undeclared egg, Yellow #5, Red #40, and Blue #1. Consumers with allergies or sensitivities to these ingredients face potential health risks.
Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.
Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.
Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.
Jacobus Pharmaceutical Company is recalling Ruzurgi (amifampridine) 10 mg tablets due to microbial contamination. Testing found that certain lots exceeded acceptable limits for aerobic bacteria, yeast, and mold.
DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.
Medina Baking and Powder Products, Inc. is recalling Chocolate Flavor (1 QT) distributed domestically because it contains egg that was not declared on the label. Consumers with egg allergies face a serious health risk.