Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Lordstown is recalling 2023 Endurance electric pickup trucks because a high-voltage cable fault may cause loss of drive power and prevent restarting.
Amlag & Quibuyen, LLC is recalling White Chocolate Guava Cheesecake (4oz) because soy lecithin and coconut are not declared on the label, risking exposure for allergic consumers.
Hood Famous Bake Shop is recalling Coconut Pandan Cheesecake because sulfite and coconut allergens are not declared on the label. Consumers with allergies should not consume this product.
Sentara Infusion Services is recalling 17 units of ETHANOL 70% 0.5ML syringes distributed nationwide due to lack of sterility assurance. The syringes may not meet required sterility standards for safe injection.
Medline is recalling 1376 surgical convenience kits nationwide due to a packaging defect that compromises the sterility of the outer wrapping. Only the kit contents remain sterile.
Sentara Infusion Services is recalling levothyroxine injectable syringes dispensed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if they received this product.
Medline Industries is recalling 981 surgical convenience kits nationwide because the perforated outer bag does not maintain sterile conditions. Only the kit contents remain sterile, not the exterior wrapping.
Sentara Infusion Services is recalling ondansetron 8mg injectable doses due to lack of sterility assurance. The medication was dispensed to patients nationwide with a beyond use date of December 29-30, 2022.
A Vietnamese Coffee Cheesecake product from Hood Famous Bake Shop is being recalled because coconut is listed in the ingredients but not in the allergen declaration, posing a risk to those with coconut allergies.
HTO Nevada's Maximum Zone2 Topical Analgesic (1oz, Lot #795CP-0003, NDC 80069-012-01) is recalled nationwide in the USA and Canada due to discoloration of the epinephrine active ingredient caused by a manufacturing deviation.
Brittle Brothers LLC is recalling multiple brittle products due to undeclared soy allergen distributed in Tennessee. Consumers with soy allergies who may have purchased these products should not consume them.
Amerisource Health Services LLC is recalling 1,416 cartons of Bupropion Hydrochloride Tablets (75 mg) nationwide due to failed impurities and degradation specifications. The tablets do not meet FDA quality standards for purity.
Sentara Infusion Services is recalling 155 bags of vancomycin injectable solution in multiple concentrations due to lack of sterility assurance. The product was dispensed nationwide for home infusion use.
Access Vascular is recalling select lots of HydroMID 4Fr catheters because they are labeled with incorrect expiration dates—the devices expire before the labeled dates. This creates a risk of using expired medical equipment in clinical settings.
Sentara Infusion Services is recalling 16 bags of nafcillin antibiotic infusion nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.
Medline Industries has recalled 120 units of Centurion Medical Products Tracheostomy Tray due to a perforated outer bag that prevents the exterior from remaining sterile, though the kit contents remain sterile.
Sentara Infusion Services is recalling Sodium Chloride 0.9% solution dispensed to patients nationwide due to lack of sterility assurance. The product was used as a diluent in home infusion therapy with Curlin or Sapphire pumps.
Sentara Infusion Services is recalling Ampicillin 12GM in NS 600M injectable solution due to lack of sterility assurance. The affected product was dispensed nationwide; patients should contact their healthcare provider.
Dobutamine injectable medication distributed by Sentara Infusion Services has been recalled due to lack of sterility assurance. If you received this medication, contact your healthcare provider for guidance.
Toyota is recalling 2022-2023 Tundra and Tundra Hybrid vehicles due to a software error that may cause the instrument panel display to go blank. This prevents drivers from seeing critical information like the speedometer and warning lights.
Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes nationwide due to lack of sterility assurance. Patients who received affected syringes should contact their physician immediately.
MEDLINE surgical convenience kits are recalled due to a perforated outer bag that prevents the kit's outer wrapping from remaining sterile. Only the contents inside the wrapper are guaranteed sterile.
Medline is recalling 30 units of surgical angio port kits due to a perforated outer bag that prevents the external packaging from being sterile, creating a contamination risk during surgical use.
Sentara Infusion Services is recalling 27 syringes of Methylprednisolone steroid due to lack of sterility assurance. The product was distributed nationwide to patients with a beyond-use date of December 29-31, 2022.
Amerisource Health Services is recalling Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications that may prevent proper drug release.