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.
Eldorado Mobility is recalling 2017 Amerivan 10 lowered-floor vehicles because trailing arm mounts may break, potentially causing loss of steering control.
Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/4 injection vials because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling 17 vials of TRI MIX 20/30/2 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid MDV Injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Cypionate injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injection because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling specific lots of Vitamin B Complex injections because the firm cannot guarantee the products are sterile.
Abbott Vascular is recalling NC Trek RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
Key Pharmacy and Compounding Center is recalling sterile compounded glutathione inhalation solution due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 20/30/1 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 100mg/mL injections due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Bicarbonate Injection because the firm cannot guarantee the product is sterile.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.
Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injections because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling Iron Special 5mL multiple-dose vials due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling CO-Q-10 Oil Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling a specific lot of sterile compounded ophthalmic drug due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.
Key Pharmacy and Compounding Center is recalling TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Cyanocobalamin injections because the firm cannot ensure the products are sterile.
Key Pharmacy and Compounding Center is recalling TRI MIX sterile compounded injections due to a lack of assurance of sterility. The affected vials were distributed in the U.S., Australia, and Canada.