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 1,871 vials of Human Chorionic Gonadotropin 20,000 Units due to a lack of assurance of sterility.
Quality Electrodynamics LLC is recalling 21 Siemens MRI coils due to potential ferrous material in the pushbutton assembly.
Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 172 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 330 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
KRS Global Biotechnology is recalling Bacteriostatic Water for Injection vials because the product lacks assurance of sterility.
KRS Global Biotechnology is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.
Medtronic Vascular is recalling 221 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.
Medtronic Vascular is recalling 26 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 152 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 3,058 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 Tablets 100 mg because FDA testing found an impurity above acceptable levels.
KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.
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 540 syringes of Sodium Bicarbonate 8.4% for IV use 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.
Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 42 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 191 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 1,701 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 102 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee sterility.
KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.