State

Kentucky product recalls

73,388 recalls have nationwide distribution and so reach Kentucky. 7,197 additional recalls listed Kentucky specifically in their distribution scope.

What the numbers show

Total: 7,197
Critical: 1,409
Severe: 2,024
Most recent: 2026-10-07

Of the 7,197 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 2,024 (28%) are Severe.

Which agencies issued them

These figures cover only the 7,197 recalls whose distribution notice names Kentucky specifically. The 73,388 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

20351–20375 of 80585

HighFDA (Devices)·Z-1734-2022·2022-09-21
GXL Acetabular Liners Packaging Defect May Cause Accelerated Wear
Exactech GXL acetabular hip implant liners in non-conforming bags may experience accelerated wear. Approximately 7,946 devices were distributed worldwide. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1721-2022·2022-09-21
Extension Set Recall Due to Connector Housing Manufacturing Defect
ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.
Product
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1714-2022·2022-09-21
Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2022·2022-09-21
Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise
Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2022·2022-09-21
FUJIFILM Surpria Imaging Software May Fail During Scanning
Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.
Product
Surpria: Software Version V3.11, V3.22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1524-2022·2022-09-21
Injectable Steroid Product Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.
Product
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1707-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure
Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2022·2022-09-21
GXL Acetabular Liners Packaged Improperly May Experience Accelerated Wear
Exactech is recalling certain GXL acetabular hip implant liners because non-conforming packaging may cause accelerated wear. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V707000·2022-09-21
2022-2023 Volkswagen Golf R and GTI radiator defect recall
Volkswagen is recalling 2022-2023 Golf R and Golf GTI vehicles because the radiator may not be properly attached to the intercooler, potentially causing coolant leaks, engine overheating, and fire risk.
Product
VOLKSWAGEN — VOLKSWAGEN GOLF R, GTI
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1529-2022·2022-09-21
Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/60 Injectable (5 ML vials) nationwide due to lack of assured sterility. The affected lots have Beyond Use Dates in August and September 2022. Contact your healthcare provider if you received this product.
Product
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1522-2022·2022-09-21
Injectable testosterone product recalled for sterility assurance defect
Carolina Infusion is recalling TEST CYP 200 MG/ML Injectable due to the manufacturing process's inability to assure sterility. The affected lots were distributed nationwide; patients should not use the product.
Product
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1725-2022·2022-09-21
GXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect
Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2022·2022-09-21
Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1536-2022·2022-09-21
Lisinopril Tablets Recalled for Embedded Metal Contamination
Lupin Pharmaceuticals is recalling Lisinopril 10 mg tablets due to discovery of a metal piece embedded in one tablet. Affected lot Q201182 was distributed nationwide to wholesalers.
Product
LISINOPRIL — LISINOPRIL (LISINOPRIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1534-2022·2022-09-21
FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure
Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.
Product
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2022·2022-09-21
ICU Medical Recalls Intravascular Connectors for Manufacturing Defect
ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.
Product
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1739-2022·2022-09-21
Isopure ACDS Hemodialysis Equipment Recalled for Electrical Shock Risk
Isopure Corp recalls its ACDS (Acidified Concentrate Distribution and Storage) system used in hemodialysis facilities due to a potential electrical safety hazard that may result in electric shock or arcing.
Product
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1726-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Improper Packaging and Accelerated Wear
Exactech is recalling 136 GXL acetabular liners used in hip implants due to non-conforming packaging that may cause accelerated wear. The devices were distributed worldwide to multiple countries.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1723-2022·2022-09-21
ICU Medical IV Connector Extension Set Recalled for Manufacturing Defect
ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.
Product
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1750-2022·2022-09-21
Surpria 64 Software Error May Prevent Image Reconstruction During Scanning
Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.
Product
Surpria 64: Software Version V3.11, V3.22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1715-2022·2022-09-21
Vascular catheter wire guide recalled for sterility testing failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units distributed nationwide and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1519-2022·2022-09-21
Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.
Product
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1530-2022·2022-09-21
TRI-MIX 30/2/20 Injectable Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/2/20 Injectable due to lack of assurance of sterility. Multiple lots were distributed nationwide to healthcare providers.
Product
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1737-2022·2022-09-21
Subdermal Needle Electrodes Recalled Due to Burn Risk During MRI Procedures
Technomed Europe is recalling disposable subdermal needle electrodes because patients may suffer burns if electrodes are left in place during MRI scanning. The manufacturer failed to provide adequate safety information in the device instructions.
Product
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1527-2022·2022-09-21
TRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/20 Injectable vials due to lack of assurance of sterility. The recall affects multiple lots distributed nationwide.
Product
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide