Severity 4 of 5
Illness, injury, or structural failure has been reported. 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.
Medtronic Vascular is recalling 573 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling six units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 1,226 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 746 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
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 1,189 vials of Methylcobalamin injection nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.
Medtronic Vascular is recalling 1,364 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 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks assurance of sterility.
Medtronic Vascular is recalling 11 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.
KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 2,760 bags of Norepinephrine in 5% Dextrose IV solution due to a lack of assurance of sterility.
Colonia Care Pharmacy is recalling 191 syringes of C-Methylcobalamin 25mg/mL injection because the product's sterility cannot be guaranteed.
Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying wires.
Medtronic Vascular is recalling 159 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing stainless-steel braid wires.
Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters due to potential loss of segment material exposing stainless-steel wires.
Colonia Care Pharmacy is recalling C-Albumin 5% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed via patient-specific prescriptions in New Jersey.
Medtronic Vascular is recalling 11 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Quality Electrodynamics LLC is recalling three Siemens 1.5T Knee Coils because unintended ferrous material may be present in the pushbutton assembly.
Medtronic Vascular is recalling 215 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.
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
KRS Global Biotechnology is recalling 878 vials of IV magnesium and calcium solution due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.