Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. 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.
Hyundai is recalling 2011-2012 Sonata vehicles because metallic debris in the engine crankshaft may restrict oil flow, potentially causing engine failure and increasing crash risk.
The Pork Rind Factory is recalling approximately 18,406 pounds of pork rinds because they contain undeclared milk and soy allergens.
Lota USA is recalling about 4,500 Glacier Bay and Schön touchless kitchen faucets sold at The Home Depot because the battery box can short circuit, overheat, or melt, posing fire and burn risks.
South Coast Specialty Compounding is recalling Bi-Est cream due to potential penicillin cross contamination. The recall covers 36 prescriptions distributed nationwide.
Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 290 packs of Cysto TUR Pack due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
South Coast Specialty Compounding is recalling Leucovorin Calcium capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Covidien LLC is recalling MediTrace Cadence Adult Multi-Function Defibrillation Electrodes due to potential wire insulation damage that may cause burns or reduced therapy.
Customed, Inc. is recalling 48 units of CESAREAN PK 4/CS surgical kits due to inadequate validation of sterilization processes and package integrity.
Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Covidien LLC is recalling MediTrace Cadence Adult Zoll defibrillation electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
Customed, Inc. is recalling 8,300 suction catheter kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
South Coast Specialty Compounding is recalling Estradiol, Estriol, and Progesterone capsules due to potential penicillin cross-contamination.
FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.
Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.
Chetak New York is recalling 300 jars of Deep Coriander Powder because they may be contaminated with Salmonella.
Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide.
Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.
Westbrook's Cannery is recalling 16-ounce jars of Horseradish Dill Pickles because the products may be underprocessed. Consumers in 11 states should stop using the product.
South Coast Specialty Compounding is recalling Estradiol and Estriol capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.
Good Seed, Inc. is voluntarily recalling soybean and mung bean sprouts due to potential Listeria monocytogenes contamination.
Covidien is recalling 56,000 sets of Physio-Control QuikCombo electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
Synthes (USA) Products LLC is recalling VEPTR Inferior Cradles because a partially formed hole may cause mechanical failure, potentially requiring surgery.