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.
Big Olaf frozen ice cream products in all flavors and sizes distributed in Florida and Ohio are being recalled due to potential Listeria monocytogenes contamination. Listeria can cause serious illness.
Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.
Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.
Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.
FDA recalls approximately 8.7 million viral transport containers that were distributed without regulatory clearance and without complying with FDA guidance for proper viral transport specifications.
Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.
Kia is recalling certain 2023 Forte vehicles due to a manufacturing error that may cause the front left steering knuckle to crack, resulting in loss of steering control and increased crash risk.
McLaren is recalling 164 2023 Artura vehicles because high-pressure fuel pipe nuts may loosen, causing fuel leaks that could lead to fires. Dealers will replace the fuel pipes at no cost.
Residential Elevators, Inc. is recalling about 31,000 home elevators sold since 1986 because young children can become trapped between the exterior and interior doors, risking serious injury or death.
North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.
Kingdom Honey Royal Honey VIP is recalled due to undeclared sildenafil, a pharmaceutical ingredient. The product was distributed nationwide; all lots are affected.
Distributor RFR, LLC is recalling SANGTER Energy Supplement Capsules because FDA analysis found they contain undisclosed sildenafil without FDA approval. The product was distributed nationwide and internationally.
SUSTANGO capsules contain the undisclosed pharmaceutical ingredient tadalafil and were marketed without FDA approval. Approximately 750 cartons were distributed nationwide via Amazon.
The FDA has recalled Dose Vital VIP Products Vital Honey With Caviar and Tongkat Ali Powder due to undeclared Tadalafil. The product was distributed in seven states and poses serious health risks.
Subaru is recalling certain 2020-2021 Outback and Legacy vehicles for a transmission control unit programming error that may cause the drive chain to slip, resulting in loss of drive power and increased crash risk.
Daimler Trucks is recalling 2022-2023 Freightliner MT45, MT45G, and Cascadia trucks because steering gears may have been incorrectly assembled and could fracture, causing loss of steering control.
Tesla is recalling certain 2021-2022 Model X vehicles due to a defect in the left or right front-row side curtain air bags that may not deploy properly when windows are lowered. Improper deployment increases the risk of injury during crashes.
DeWALT is recalling approximately 1.36 million 12-inch sliding compound miter saws because the rear safety guard can break or detach, creating a risk of projectiles and laceration injuries. Consumers should stop using the saws and contact DeWALT for a free repair.
BD Intraosseous Needle Kits have been recalled due to mechanical failures that could prevent emergency vascular access. Affected units nationwide and in Canada may experience stylet removal problems, safety mechanism failures, or driver malfunction.
Fuchs North America is recalling Za'atar Seasoning (lot 252491) because an oregano sub-ingredient tested positive for Salmonella. The product was distributed to one commercial buyer.
Integra LifeSciences is recalling CereLink ICP Monitors due to electrical interference causing intracranial pressure readings to drift out of range. Affected devices may display an error message indicating sensor or extension cable failure.
Baxter Healthcare's ABACUS TPN calculation software poses a potential risk of medication error. The FDA issued a Class I recall; healthcare providers should contact the manufacturer for guidance.
Valor Compounding Pharmacy is recalling Nifedipine WSP 0.2% Ointment due to potency variability. Some batches may be subpotent or superpotent, affecting safety and efficacy.
Pfizer is recalling 54,000 vials of Propofol Injectable Emulsion (Lot DX9067) due to presence of particulate matter identified as a beetle. No illnesses or injuries have been reported.
Daikin Comfort Technologies is recalling about 298,300 evaporator coil drain pans that can overheat, melt, and deform, creating a fire hazard. The company has received 26 fire reports, with no injuries reported.