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.
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
Medtronic implantable defibrillators may deliver reduced or no energy during therapy due to a rare electrical defect. Approximately 1,914 units with a specific feedthrough component are affected and distributed worldwide.
Medtronic implantable cardioverter defibrillators (CRT-Ds) may fail to deliver adequate energy during high-voltage treatment due to a manufacturing defect in the feedthrough component, affecting 373 units.
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a defective feedthrough component. The FDA classified this as a Class I recall affecting 2,884 devices.
Medtronic is recalling 7 implantable cardioverter-defibrillators that may fail to deliver electrical therapy during critical heart rhythms. The defect affects devices with a specific feedthrough component.
Certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may produce reduced or no energy output during high voltage therapy due to a defective feedthrough component.
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. The recalled devices contain a specific feedthrough component.
Medtronic recalled certain implantable defibrillators that may fail to deliver electrical therapy during critical heart rhythm events due to a manufacturing defect in the device feedthrough.
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy delivery due to a defective feedthrough component. No injuries have been reported, but patients may not receive proper treatment for life-threatening heart rhythms.
Aquamar Inc is recalling Kanimi Easy Roll Crab Flavored Seafood due to undeclared wheat and egg allergens that pose a serious health risk to allergic consumers.
Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a manufacturing issue. The recall affects 1,354 units distributed in the United States and internationally.
Zuru is recalling about 7.5 million Robo Alive Junior Baby Shark bath toys due to hard plastic top fins that pose risks of impalement, laceration, and puncture injuries to children. Twelve reported injuries have been documented, including nine cases requiring stitches or medical attention.
Research Products is recalling about 36,200 steam humidifiers with faulty electrode connector wires that can loosen, cause arcing, and overheat. The company has received 103 reports of overheating, including 10 residential fires causing over $10 million in damage.
Van Leeuwen brand ice cream may contain undeclared walnuts. Consumers with walnut allergies should not consume this product.
SOFT HANDS Alcohol Antiseptic 80% hand sanitizer is recalled nationwide due to FDA detection of methanol contamination. Approximately 7,303 gallons were distributed with manufacture dates from March to August 2020.
NOxBOXi Nitric Oxide Delivery System devices may malfunction due to misaligned check valves, risking gas leaks and therapy interruption. This could lead to oxygen desaturation if the device fails during patient use.
Jarman's Midwest Cleaning Systems recalled 2,365 gallons of 80% alcohol antiseptic hand sanitizer nationwide due to FDA-detected methanol contamination. Consumers should stop using affected products immediately.
DIBE LLC is recalling TETAS Mireya candy due to undeclared soy and walnut allergens. Consumers with allergies to these ingredients should not consume the product.
Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.
Meijer Inc is recalling Frederik's by Meijer Dark Chocolate Almonds due to undeclared milk. The product was distributed to Meijer stores in six Midwest states.
BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.
Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.
The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.
DIBE LLC is recalling TETAS Mireya SABOR Galleta Maria cookies due to undeclared soy and wheat allergens. Consumers with allergies to these ingredients should not consume the product.