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 20 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 488 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 219 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
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.
Medtronic Vascular is recalling 56 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 1,495 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 121 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 5 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 1,464 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 4,105 syringes of Lidocaine and Epinephrine due to a lack of assurance of sterility.
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 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.
KRS Global Biotechnology is recalling 1,044 syringes of Ketamine in 0.9% Sodium Chloride because the product lacks assurance of sterility.
KRS Global Biotechnology is recalling 649 droptainers of a sterile ophthalmic solution because the company cannot ensure the product's sterility.
KRS Global Biotechnology is recalling ePHEDrine Sulfate syringes nationwide because the company cannot guarantee the product is sterile.
KRS Global Biotechnology is recalling 708 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 100 mg because FDA testing found an impurity above acceptable levels.
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 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.01% due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 934 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.
KRS Global Biotechnology is recalling 647 vials of Sermorelin and related peptides because the company cannot ensure the products are sterile.
KRS Global Biotechnology is recalling 528 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility. The product was distributed nationwide.
Colonia Care Pharmacy is recalling 15 syringes of C-MB12 NAC injection solution because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
KRS Global Biotechnology is recalling Isoproterenol HCL IV bags because the company cannot ensure the product is sterile.