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.
Terex is recalling 2006-2014 TLM series aerial devices installed on Ford F550 vehicles due to a potential frame crack that could cause loss of control.
Sunbeam is recalling about 151,600 Holmes ceramic heaters because they can overheat and pose a fire hazard. Consumers should stop using the units and contact Sunbeam for a refund.
Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.
Lithonia Lighting is recalling Quantum ELM and ELM2 emergency lights because the circuit board can overheat and cause a fire. Consumers should contact the company for a free repair kit.
Teva Pharmaceuticals is recalling QVAR inhalation aerosol canisters because the delivery system and valve are defective.
Fresenius Medical Care is recalling specific lots of phosLo (calcium acetate) GelCaps due to cross-contamination with a tricyclic antidepressant found on the packaging.
Maquet Datascope is recalling 11,881 Intra-Aortic Balloon Pump units worldwide due to a potential fan assembly failure that could cause the power supply to overheat and shut down without warning.
Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 Nails because a manufacturing error caused set screws to be inserted too deep.
Siemens Medical Solutions is recalling 120 550 TxT Treatment Tables because they may lose calibration during treatment, posing a risk of patient mistreatment.
Zydus Pharmaceuticals USA Inc. is recalling 10,200 bottles of Promethazine Hydrochloride 25 mg tablets because atenolol 25 mg tablets were found mixed into the bottles.
Teva Pharmaceuticals is recalling 17,181 bottles of 2 mg Buprenorphine Hydrochloride Sublingual Tablets because stability testing revealed high out-of-specification impurity levels.
Champion Bus is recalling 2014 Defender shuttle buses because transmission software may cause unintended acceleration, increasing crash risk.
Wells Enterprises is recalling Blue Bunny Premium Ice Cream because it may contain egg, which is not listed on the ingredient label.
Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.
Independent Nutrition Center is recalling Red Yeast Rice High Potency Dietary Supplement because it contains excessive levels of lovastatin, an FDA-approved drug.
Schindele Enterprises is recalling MiracleZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.
Tendex is recalling P-Boost Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.
Terumo is recalling one CDI Blood Parameter Monitoring System unit in Iowa due to potential inaccuracies in blood gas and hemoglobin measurements.
Emparedados Boricua is recalling 136 units of Pollo & Queso sandwiches in Puerto Rico due to undeclared eggs.
Aqua Filter Fresh, Inc. is recalling 3 and 5-gallon spring water bottles due to positive lab results for Coliforms and non-speciated E. coli.
Philips Medical Systems is recalling specific lithium ion batteries for IntelliVue Patient Monitors because they may overheat, ignite, or explode after extended use.
Siemens is recalling five MAMMOMAT Inspiration mammography units because the PC monitor holder can break, causing the monitor to fall and potentially injure users.
Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate bottles due to potential contamination. The product is used in hemodialysis machines.
Mitsubishi is recalling 2014 Lancer Evolution and Ralliart vehicles because insufficient clearance between the power steering tube and crossmember brace may cause fluid leaks, increasing crash and fire risks.
Lotus is recalling 860 Elise, Exige, and Evora vehicles because the oil cooler hose may detach, posing fire and crash risks.