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.
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.
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software error that displays an incorrect 9-grid overlay instead of the correct 15-grid overlay in Live or Record mode, affecting measurement accuracy with OptiCross 18 catheters.
Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.
Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.
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.
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 is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.
Nova Ortho-Med is recalling the MONARCH ROLLATOR PURPLE due to a fall hazard: the backrest may disengage when users shift from a slouched to upright seated position.
Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.
Boston Scientific AVVIGO+ Multi-Modality Guidance System displays incorrect grid overlay when connected to OptiCross 18 catheters in Live or Record mode due to a software anomaly. The wrong overlay could affect reference depth settings used in vascular imaging procedures.
Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error that displays incorrect 9-grid marks instead of 15-grid marks in Live and Record modes. This display error could affect physicians' ability to set proper reference depths during intravascular imaging procedures.
Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to 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.
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.
Volvo Trucks is recalling certain 2020-2025 trucks with Bendix EC80 Advanced Electronic Control Units because electrical noise may cause the ECU to misprocess commands or stop working.
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.
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.
Volvo Trucks North America is recalling one 2025 VNL truck because a software error may prevent the anti-lock brake system warning light from illuminating.
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.
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.
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.
Accord Healthcare is recalling 11,214 vials of Cisplatin Injection due to failed impurity and degradation specifications. The recalled lot was distributed nationwide in the United States and Puerto Rico.
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error causing incorrect grid overlay display when used with OptiCross 18 catheters, which could affect measurement accuracy.