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.
Rolls-Royce is recalling 2019-2022 Phantom vehicles because the central display may not raise correctly, partially blocking the rearview camera image.
Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.
Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.
Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.
Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.
Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injection Solution because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received the affected product.
W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.
Red Mountain Compounding Pharmacy is recalling pyridoxine HCL (vitamin B6) injectable solution due to lack of assured sterility. Approximately 494 patients in multiple states received affected prescriptions.
Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.
Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.
Usines Giant Factories is recalling about 168 gas water heaters with Emerson control valves that can short circuit, overheat, and release carbon monoxide. The company will replace the control valve free of charge.
W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.
Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.
Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.
Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.
Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.
W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.
AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.
Simple Mills has recalled Almond Flour Crackers with fine ground sea salt because they contain undeclared milk allergen. The product was distributed across 36 states.
FCA US is recalling 2020 Alfa Romeo Giulia vehicles because some may have tires with a lower load rating than intended, increasing crash risk.
Oshkosh is recalling 2020-2021 S-Series vehicles because a machining defect may cause the power steering pump shaft seal to break, resulting in a loss of steering assist.
USDA FSIS issued a public health alert for Citterio Premium Italian-Style Salame Sticks due to possible Salmonella contamination linked to a multistate outbreak.
Tesla is recalling certain 2017-2021 Model 3, S, X, and Y vehicles due to a software error that may cause false forward-collision warnings or unexpected automatic emergency brake activation. No injuries have been reported.
Chrysler is recalling 2021 Dodge Durango vehicles because the rear spoiler may not be properly aligned and could detach during liftgate use, creating a road hazard. Dealers will replace the spoiler free of charge.