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.
Siemens is recalling two Artis Q zeego X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 131 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling eight Artis X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 73 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury.
Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.
Siemens is recalling 15 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.
Jayco is recalling 2019-2020 White Hawk travel trailers because incorrectly wired breakaway switches may prevent trailer brakes from functioning if the trailer separates from the tow vehicle.
Ford is recalling certain 2012-2017 Focus vehicles because a malfunctioning valve may cause the engine to stall while driving, increasing crash risk.
Premier Pharmacy Labs is recalling 6,423 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Premier Pharmacy Labs is recalling 40 bags of Isoproterenol HCL in D5W due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Ethicon is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to a reported incidence of intraoperative bleeding.
Premier Pharmacy Labs is recalling 1,834 vials of Mitomycin Preservative Free Irrigation because FDA inspections found insufficient environmental controls that may compromise sterility.
Premier Pharmacy Labs is recalling 1,235 bags of Isoproterenol HCL in D5W nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.
Premier Pharmacy Labs is recalling 13,150 vials of Sodium Bicarbonate Injection 8.4% nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.
Premier Pharmacy Labs is recalling 1,040 syringes of Phenylephrine HCL injection nationwide because FDA inspections found insufficient environmental controls that may compromise sterility.
Mai Cuisine LLC is recalling 22 packages of Spicy Shrimp Tempura Roll in Oregon due to undeclared egg.
Premier Pharmacy Labs is recalling 86 syringes of Dexamethasone Sodium Phosphate due to potential sterility issues found during an FDA inspection.
Premier Pharmacy Labs is recalling Naloxone HCL Preserved Injection because FDA inspections found insufficient environmental controls and lack of process validations, raising concerns about sterility assurance.
Premier Pharmacy Labs is recalling 578 vials of Brilliant Blue Ophthalmic Injection due to a lack of assurance of sterility identified during an FDA inspection.
Premier Pharmacy Labs is recalling 125 bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution due to a lack of assurance of sterility.
Premier Pharmacy Labs is recalling 606 bags of Isoproterenol HCL in D5W because FDA inspections found insufficient environmental controls that may compromise sterility.
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.
Premier Pharmacy Labs is recalling 323 vials of Lidocaine 0.5%/Phenylephrine 0.75% Injection due to a lack of sterility assurance identified during an FDA inspection.
H J Harkins Company is recalling 40 bottles of Acetaminophen Children's Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Mai Cuisine LLC is recalling 35 packages of Spicy Shrimp Tempura Crunch Roll distributed in Oregon due to undeclared egg.