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.
Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Clinical Specialties Compounding Pharmacy is recalling specific lots of laser ophthalmic drops due to FDA inspection findings regarding quality control and sterility assurance.
Zimmer, Inc. is recalling Fukuda-type retractors because they may fracture at the grooves during surgical use. This recall expands a 2010 action to include seven additional lots.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because an electrical short in the connector caused heat accumulation and melted wiring.
Clinical Specialties Compounding Pharmacy is recalling Methionine/Choline/Inositol/B-12 products due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Hoover Mill, Inc. is recalling 7,068 bags of Arnett's Self Rising Corn Meal in Alabama due to high levels of aflatoxin.
Clinical Specialties Compounding Pharmacy is recalling Medroxyprogesterone 50 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to an electrical short that caused heat accumulation and melted wiring.
Ortho-Clinical Diagnostics is recalling 31 units of the ORTHO Assay Software Server because an electrical short caused heat accumulation and melted wiring.
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic Systems because an electrical short caused heat accumulation that melted wiring and connectors.
Hannaford Gourmet Cookie Platters are being recalled because they may contain undeclared tree nuts, posing a risk to consumers with allergies.
Hoover Mill, Inc. is recalling Arnett's Plain Corn Meal in Alabama due to high levels of aflatoxin.
Hoover Mill, Inc. is recalling specific lots of Dixie Lily Stone Ground Meal in Alabama due to high levels of aflatoxin.
Baxter Healthcare is recalling specific lots of 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.
Baxter Healthcare Corp. is recalling specific lots of Metronidazole Injection USP due to a manufacturing defect that may compromise sterility.
Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 2% Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Spartan Motors is recalling 2011-2013 Transit Bus Chassis Cabs because a faulty harness may cause the fuel pump to shut off, leading to engine stalling.
TMC Group is recalling 2006-2013 Ameritrans E-Series buses because a wheelchair lift cable may cause a short circuit and fire.
Honda is recalling specific 2013 Accord vehicles because a fuel tank neck defect may cause a fuel leak, increasing the risk of fire.
Mitsubishi is recalling 2013 Outlander Sport vehicles due to a defective front stabilizer link weld that may damage tires or brake hoses, increasing crash risk.
TCI is recalling two school bus models because a wheelchair lift cable may not clear the lift, potentially causing a short circuit and fire.
Hospira is voluntarily recalling 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.
Medtronic is recalling INDURA 1P Intrathecal Catheters because the previous connector design has a greater potential for misalignment and occlusion.
Medtronic is recalling SynchroMed EL pumps due to potential internal electrical shorting that may cause therapy loss.
Taylor Farms is recalling Black Forest Ham and Cheese Pretzel Rolls due to potential undeclared tree nut allergens.