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.
Southern Sisters Gourmet is recalling Oven Fried Chicken because it contains undeclared wheat, a major food allergen.
Medtronic MiniMed is recalling 27 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.
Abbott is recalling Precision Xtra Blood Glucose & Ketone Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA and could lead to infection.
Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.
Southern Sisters Gourmet is recalling Butter Pecan Cheeseball mix because it contains undeclared milk, wheat, soy, and almond.
Southern Sisters Gourmet is recalling Caramel Apple Cobbler because it contains wheat, an allergen not listed on the label.
Medtronic MiniMed is recalling 10 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
Mavidon is recalling PediaPrep Tubes and Single use cups because samples were found contaminated with Burkholderia cepacia during an FDA inspection.
LivaNova is recalling 2,683 VNS Therapy Programmer Model 3000 units because a specific sequence of actions may trigger a false positive warning, potentially leading to unnecessary medical intervention.
Abbott is recalling Optium EZ Blood Glucose Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA, posing a risk of infection.
Intellijoint Surgical is recalling its Navigation System software because it may incorrectly calculate femur resection depth during total knee arthroplasty.
Medtronic MiniMed is recalling 73,028 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Carroll-Baccari, Inc. is recalling Mavidon CardioPrep Single products because samples were found contaminated with Burkholderia cepacia.
Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
Medline Industries is recalling 117,874 units of Winged Sponges Presaturated W/PVP because voids in the packaging seal caused a loss of sterility.
Medtronic MiniMed is recalling 72,850 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 36,143 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.
Skytron is recalling 43 monitor brackets because a weld may fail, causing the display to fall and potentially injure users.
Carroll-Baccari, Inc. is recalling LemonPrep Tubes and Single use cups because samples tested positive for Burkholderia cepacia during an FDA inspection.
Capintec is recalling Captus 4000e Thyroid Uptake Systems because insufficiently tapped screw holes may allow the collimator assembly to fall and contact patients or operators.
Abbott is recalling FreeStyle Precision H meters because unapproved instructions for disinfection and multi-patient use may lead to infection.
Subaru is recalling 2019 Crosstrek vehicles because the rear seat belt locking mechanism may not function as intended, increasing injury risk in crashes.
Daimler Vans USA is recalling 2019 Sprinter vans because the Operator's Manual may contain incorrect information about the automatic parking function, potentially increasing crash risk.
General Motors is recalling 2019-2020 Chevrolet Bolt EVs because a rear door cable may be too long, potentially causing the door to open unintentionally while driving.