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.
Pallimed Solutions is recalling DMSO Aqueous Irrigation 50% because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling 23 vials of compounded Cidofovir Ophthalmic Solution nationwide due to FDA inspectional findings regarding sterility assurance.
Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.
Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.
Nova Biomedical is recalling Nova Max Plus Monitor Systems because the test strips may produce false abnormally high glucose readings.
Pallimed Solutions is recalling Quadmix Injection vials because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Pallimed Solutions is recalling Gentamicin Sulfate Irrigation nationwide because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling Atropine Injection compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.
SpineFrontier, Inc. is recalling nine Invue Solid Drivers because the nipple broke off during use, potentially affecting spinal surgery.
Pallimed Solutions is recalling Bacteriostatic Water for Injection because FDA inspections found quality control issues that impacted sterility assurance.
Pallimed Solutions is recalling compounded Cyclosporine Ophthalmic because FDA inspections raised concerns about quality control and sterility assurance.
Pallimed Solutions is recalling Tacrolimus Ophthalmic nationwide due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling 261 vials of compounded HCG Chorionic Gonadotropin nationwide due to FDA inspectional findings regarding sterility assurance.
Pallimed Solutions is recalling Methylcobalamin PF vials nationwide due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling compounded Hydroxyprogesterone CAPR. (G.S.) due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling Diazepam Injectable vials because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling Testosterone Cypionate/Propionate Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.
Pallimed Solutions is recalling 862 vials of Trimix Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling Nandrolone Decanoate Injectable vials because FDA inspectional findings raised concerns about sterility assurance and quality control.
Pallimed Solutions is recalling 246 vials of BiMix Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.
Pallimed Solutions is recalling MIC with B6 and B12 vials because FDA inspectional findings raised concerns about quality control procedures and sterility assurance.
Pallimed Solutions is recalling 71 vials of Buprenorphine HCl Veterinary Injection nationwide due to FDA inspectional findings regarding sterility assurance.
CareFusion is recalling 14,112 manual resuscitators because a blocked oxygen connector may prevent supplemental oxygen from reaching the patient.
Silver Eagle is recalling 1999-2001 VAST-20W and 2001 CSL-20W trailer converter dollies because a structural defect in the axle beam can cause failure and loss of control.