State
73,100 recalls have nationwide distribution and so reach Kentucky. 7,194 additional recalls listed Kentucky specifically in their distribution scope.
Of the 7,194 recalls naming Kentucky we have scored against our rubric, 1,409 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,706 (24%) are Severe.
Which agencies issued them
These figures cover only the 7,194 recalls whose distribution notice names Kentucky specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.
Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.
Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.
Merit Medical Systems is recalling 429 IntelliSystem Inflation Devices due to a potential hole in the sterile barrier that could allow pathogen exposure and infection.
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.
Certain lots of Beckman Coulter Access TSH reagent packs may produce erroneously low thyroid-stimulating hormone results. Affected kits should be verified before clinical use.
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.
A software anomaly in the Boston Scientific AVVIGO+ Multi-Modality Guidance System causes an incorrect grid overlay display when used with certain catheters. The wrong overlay may lead to incorrect measurement references during imaging procedures.
Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
Hydration Labs Inc. is recalling Flavor#115 Electrolytes (3.78L BIB units) distributed nationwide and in Canada because the product is labeled as electrolytes but actually contains caffeine.
Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.
Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.
Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.
Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.
BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.
Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment because the product contains undeclared inactive ingredients not listed on the label.
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
Olympus is recalling 45 units of the EVIS EXERA III Video System Center (Model CV-190) that fail to start due to power supply defects. The endoscopy device was distributed nationwide.
A software anomaly in Boston Scientific's AVVIGO+ system causes an incorrect 9-grid overlay to display instead of the correct 15-grid overlay when connected to OptiCross 18 catheters, potentially affecting clinical interpretation of vascular imaging.
Merit Medical Systems recalls 110,650 Monarch Inflation Devices due to manufacturing defects that create holes in the sterile barrier. The devices are used in cardiovascular procedures and may pose contamination risk.
Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.
Boston Scientific is recalling the AVVIGO+ Guidance System for a software defect that displays incorrect grid overlays when connected to OptiCross 18 catheters. The error affects Live and Record modes only; no injuries have been reported.
Walmart is recalling Great Value Cherry Mixed Fruit cups nationwide because FD&C Red No 3 was not declared as an ingredient on the label.