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.
KRS Global Biotechnology is recalling Sermorelin Acetate vials due to a lack of assurance of sterility. The recall covers 341 vials distributed nationwide.
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because sterility cannot be guaranteed. The product was distributed via patient-specific prescriptions in New Jersey.
KRS Global Biotechnology is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Medtronic Vascular is recalling 185 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.
KRS Global Biotechnology is recalling 948 vials of IV Vitamin B12 products due to a lack of assurance of sterility. The recall is nationwide.
Medtronic Vascular is recalling 129 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.
KRS Global Biotechnology is recalling 878 vials of IV magnesium and calcium solution due to a lack of assurance of sterility.
Medtronic Vascular is recalling 12 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
KRS Global Biotechnology is recalling 150 vials of Sodium Citrate and Gentamicin solution due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling ePHEDrine Sulfate syringes nationwide because the company cannot guarantee the product is sterile.
Colonia Care Pharmacy is recalling specific vials of Calcium Gluconate 1% Injection because the sterility of the product cannot be guaranteed.
Colonia Care Pharmacy is recalling C-Hydroxocobalamin 5 mg/mL injection syringes because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Volvo Bus is recalling 2018-2020 9700 models because passenger seat belt attachments may not anchor properly, increasing injury risk in crashes.
Medtronic Vascular is recalling 5 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 62 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
KRS Global Biotechnology is recalling Lidocaine HCl 2% syringes nationwide due to a lack of assurance of sterility. The recall affects 4,450 syringes.
Colonia Care Pharmacy is recalling 7 vials of C-Urea 40% Bladder Instill because the product's sterility cannot be guaranteed.
Medtronic Vascular is recalling 206 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.
Medtronic Vascular is recalling 17 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
KRS Global Biotechnology is recalling 7,685 vials of Neostigmine Methylsulfate due to a lack of assurance of sterility. The recall is nationwide.
Colonia Care Pharmacy is recalling specific lots of C-Tacrolimus 0.03% ophthalmic suspension because the sterility of the product cannot be guaranteed.