State

Kentucky product recalls

72,986 recalls have nationwide distribution and so reach Kentucky. 7,165 additional recalls listed Kentucky specifically in their distribution scope.

What the numbers show

Total: 7,165
Critical: 1,399
Severe: 1,694
Most recent: 2026-09-09

Of the 7,165 recalls naming Kentucky we have scored against our rubric, 1,399 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,694 (24%) are Severe.

Which agencies issued them

These figures cover only the 7,165 recalls whose distribution notice names Kentucky specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6676–6700 of 80151

ModerateFDA (Devices)·Z-1856-2025·2025-06-04
Glidewell HT Implant Twist Drill recalled due to packaging mix-up
Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm devices due to a packaging mix-up that resulted in incorrect finished devices being placed in packages.
Product
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1831-2025·2025-06-04
Ortho Clinical Diagnostics Vitros Calcium Reagent Recalled Due to Storage Conditions
Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent is being recalled because transit delays caused by severe thunderstorms may have stored products outside recommended cold chain conditions, potentially leading to incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0452-2025·2025-06-04
Theophylline Extended-Release Tablets recalled for dissolution test failure
Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.
Product
THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1884-2025·2025-06-04
Male-Female Midsection components from ELEOS Segmental Limb Salvage System
Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.
Product
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Mal
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1832-2025·2025-06-04
ORTHO CLINICAL DIAGNOSTICS VITROS Phosphorus Reagent Recall
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS reagent units may have been stored outside recommended cold chain conditions due to severe thunderstorms, risking incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1846-2025·2025-06-04
Abbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure
McKesson Medical-Surgical is recalling Abbott Point of Care Test Creatinine I-STAT cartridges distributed nationwide after transit delays during severe thunderstorms caused improper storage conditions, increasing the risk of incorrect or delayed test results.
Product
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1882-2025·2025-06-04
Segmental Stem Bowed 152MM components recall potential seal breach
Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.
Product
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1827-2025·2025-06-04
HemoCue Glucose 201 Analyzer Microcuvettes Recalled for Storage Conditions
HemoCue INC F/Glucose 201 Analyzer microcuvettes are being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside recommended conditions, which could cause incorrect or delayed test results.
Product
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1822-2025·2025-06-04
Siemens ADVIA Centaur HCY Calibrator packs recalled for calibrator instability
Siemens Healthcare Diagnostics is recalling certain lots of ADVIA Centaur HCY Calibrator (2 Pack) due to calibrator instability that causes increased positive bias and fails to meet reference interval specifications in the Instructions for Use.
Product
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1845-2025·2025-06-04
Abbott Diagnostics HIV Combo Calibrator Affected by Cold Chain Exposure
Abbott Diagnostics ARCHITECT HIV COMBO Calibrator units may have been exposed to improper storage temperatures due to transit delays during severe thunderstorms, potentially affecting test accuracy.
Product
ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1853-2025·2025-06-04
Abbott Diagnostics Alinity I Anti-CCPS Reagent Recall
Abbott Diagnostics Alinity I Anti-CCPS Reagent is being recalled due to transit delays from severe thunderstorms that may have exposed the product to storage conditions outside the manufacturer's recommendations, potentially causing incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1829-2025·2025-06-04
BD Microbiology MacConkey II Agar Media Storage Condition Recall
BD Microbiology MacConkey II Agar media may have been stored outside recommended temperature conditions due to transit delays from severe thunderstorms, potentially resulting in incorrect or delayed test results.
Product
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1880-2025·2025-06-04
Segmental Stem Components Recalled for Potential Tyvek Seal Breach
Onkos Surgical is recalling Segmental Stem components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise sterility.
Product
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1835-2025·2025-06-04
Ortho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Total Bili-Alkp XT (L-Sequester) reagent due to cold chain storage failures during transit caused by severe thunderstorms, which may result in incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2025·2025-06-04
Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure
Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2025·2025-06-04
Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
Product
BROMFENAC OPHTHALMIC SOLUTION 0.09% — BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1825-2025·2025-06-04
Abbott Rapid DX Cholestec LDX Lipid Profile Test Cassettes Recall
Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1821-2025·2025-06-04
Atellica IM Homocysteine Calibrator recalled for assay instability
Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.
Product
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1840-2025·2025-06-04
Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator units experienced transit delays due to severe thunderstorms, potentially exposing products to storage conditions outside the manufacturer's recommendations. This may increase the risk of incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1824-2025·2025-06-04
Abbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion
Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1836-2025·2025-06-04
Ortho Clinical Diagnostics Anti-B Bioclone diagnostic reagent recalled
Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test results.
Product
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1855-2025·2025-06-04
HemoCue Glucose Control Kit Affected by Improper Storage During Transit
HemoCue Glucose Aqueous Control Kit units may have been stored outside recommended conditions due to transit delays during severe thunderstorms, potentially affecting test result accuracy.
Product
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1843-2025·2025-06-04
Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays
Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.
Product
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1858-2025·2025-06-04
Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly
C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.
Product
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Cataly
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1854-2025·2025-06-04
Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set Recall
Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set units may have been exposed to improper storage conditions during transit due to severe thunderstorms, which could result in incorrect or delayed test results.
Product
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Category
Medical Device
Distribution
Distributed nationwide