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.
Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder that may be contaminated with Salmonella.
Pharmakon Pharmaceuticals is recalling 200 pre-filled syringes of Glycopyrrolate 0.2 mg/ml because they contain undeclared benzyl alcohol.
Alkermes is recalling 4,364 vials of VIVITROL (naltrexone) nationwide because customer complaints reported the product failed to deliver the dose.
Ford is recalling specific 2014 Focus, 2014 Escape, and 2015 Lincoln MKC vehicles because a fuel delivery module may crack, causing low fuel pressure and potential vehicle stalls.
Ford is recalling 2015 F-650 and F-750 SD trucks because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.
Mitsubishi is recalling 2010-2014 i-MiEV electric vehicles because the brake vacuum pump may stop functioning, potentially increasing stopping distance and crash risk.
Genera is recalling specific aftermarket headlamp assemblies for 2013-2014 Acura ILX vehicles due to overheating risks that could cause smoke, melting, or fire.
Gillig is recalling 231 model year 2014 Low Floor transit buses because a fuel filter defect may cause the engine to stall unexpectedly, increasing the risk of a crash.
New Flyer is recalling 2014 transit buses because a fuel filter defect may cause the engine to stall without warning, increasing the risk of a crash.
General Motors is recalling specific 2013-2014 Cadillac XTS and Chevrolet Impala vehicles because the air bag control module may be in manufacturing mode, preventing deployment in a crash.
Ben Venue Laboratories is recalling 7,172 vials of Cytarabine for Injection due to potential crimp defects that may affect sterility.
AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.
Healix Infusion Therapy is recalling 50 fentanyl syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.
Tnuva USA is recalling approximately 8,316 pounds of Mom's Chicken Extra Thin Cutlets due to possible Listeria monocytogenes contamination. No illnesses have been reported.
CaCoCo, Inc. is recalling specific lots of Superfood Drinking Chocolate because an organic ingredient used in the product is under recall for potential Salmonella contamination.
Ortho Development is recalling specific knee implant components because defective foil pouches allowed air to enter, potentially degrading the material properties of the implants.
Childrens Medical Ventures is recalling Gel-E Donut and Squishon 2 gel pillows because of visible mold. The mold was identified as Cladosporium and Penicillium fungi.
Healix Infusion Therapy is recalling 220 fentanyl prefilled syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.
Goodman Company is recalling approximately 233,500 packaged terminal air conditioners and heat pumps because power cords can overheat, posing fire and burn risks.
Synthes, Inc. is recalling specific lots of the DePuy Synthes Craniomaxillofacial Distraction System because the devices may reverse after surgery.
Hospira Inc. is recalling 123,900 vials of Dobutamine Injection due to the presence of glass particulate matter and a discolored solution.
Healix Infusion Therapy is recalling 48 bags of compounded fentanyl in Texas and Georgia because the supplier recalled the source drug due to loose or missing vial crimps.
Healix Infusion Therapy is recalling 12 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility from a supplier recall.
CaCoCo, Inc. is recalling specific lots of Superfood Drinking Chocolate because an organic ingredient used in the product is under recall for potential Salmonella contamination.
Fresenius Kabi USA, LLC is recalling 56,060 vials of Propranolol Hydrochloride Injection because the active ingredient supplier received citations for critical manufacturing deficiencies.