State

Kentucky product recalls

72,913 recalls have nationwide distribution and so reach Kentucky. 7,164 additional recalls listed Kentucky specifically in their distribution scope.

What the numbers show

Total: 7,164
Critical: 1,399
Severe: 1,694
Most recent: 2026-09-09

Of the 7,164 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 7,164 recalls whose distribution notice names Kentucky specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2001–2025 of 80077

HighFDA (Devices)·Z-2103-2026·2026-05-13
Medline Convenience Kits Recalled Over Sterilization Calibration Issues
Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.
Product
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2101-2026·2026-05-13
Medline Medical Device Convenience Kits Sterilization Calibration Recall
Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.
Product
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CAR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0512-2026·2026-05-13
DELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from perforations that may compromise sterility. The recall affects 37,215 bags distributed nationwide.
Product
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2127-2026·2026-05-13
Medline Arthroscopy Convenience Kits Recalled Due to Sterilization Equipment Calibration
Medline is recalling five models of arthroscopy convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2100-2026·2026-05-13
Medline Convenience Kits surgical packs sterilization calibration recall
Medline Industries is recalling three models of surgical convenience kits—Lithotomy Packs and Lap Basin—due to calibration issues with sterilization equipment that could affect the sterility assurance of the products.
Product
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2112-2026·2026-05-13
Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.
Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2117-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2083-2026·2026-05-13
One Step UTI in vitro diagnostic test recalled for missing FDA approval
DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.
Product
One Step UTI in vitro diagnostic test REF: 3374
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2129-2026·2026-05-13
Medline Surgical Gowns Sterilization Calibration Issues
Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Product
See complete list in RES, exceeds character limit. Medline Surgical Gowns
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2088-2026·2026-05-13
One Step P in vitro diagnostic test lacks FDA premarket clearance
The One Step P in vitro diagnostic test (REF 8194) was distributed without required FDA premarket clearance or approval. The manufacturer DFI Co., Ltd. is recalling the device.
Product
One Step P in vitro diagnostic test REF: 8194
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2074-2026·2026-05-13
DEX Ophthalmic Tissue Forceps recalled for instruction updates
Katalyst Surgical is issuing a Field Safety Corrective Action for 670 units of DEX Ophthalmic Tissue Forceps (Model DVF4019-25) due to updates required in the instructions for use. The device was distributed worldwide.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0516-2026·2026-05-13
Duloxetine Delayed-Release Capsules 20 mg Recalled for Impurity
Ajanta Pharma USA Inc. is recalling Duloxetine 20 mg delayed-release capsules (Lot PA10734, expiration June 2026) because they contain elevated levels of N-nitroso-Duloxetine impurity above the FDA-recommended limit.
Product
DULOXETINE — DULOXETINE (DULOXETINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2082-2026·2026-05-13
One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.
Product
One Step 10A in vitro diagnostic test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2026·2026-05-13
Duloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg (Lot PA07434, expiration May 2026) because testing found N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.
Product
DULOXETINE — DULOXETINE (DULOXETINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2122-2026·2026-05-13
Medline Convenience Kits sterilization calibration issue recalled
Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2111-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.
Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Mo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2130-2026·2026-05-13
Medline Surgical Packs recalled due to sterilization equipment calibration issues
Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.
Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall
Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2087-2026·2026-05-13
One Step K in vitro diagnostic test recall for missing FDA clearance
DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.
Product
One Step K in vitro diagnostic test REF: 81A4
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0520-2026·2026-05-13
Enalapril Maleate 20 mg tablets recalled for out-of-specification impurities
JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate 20 mg tablets nationwide due to out-of-specification results in organic impurities testing. Affected lot GEH25023 was distributed nationwide.
Product
ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0514-2026·2026-05-13
Duloxetine Delayed-Release Capsules Recalled for Impurity Above Limit
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm.
Product
DULOXETINE — DULOXETINE (DULOXETINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2099-2026·2026-05-13
Medline Convenience Kits Recalled for Potential Sterilization Calibration Issues
Medline Industries is recalling multiple convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. Approximately 5,497 units were affected and distributed nationwide.
Product
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2072-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Safety Corrective Action Recall
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2080-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps (Model DVF4034-27) distributed worldwide. The specific hazard or reason for the recall is not stated in the available source information.
Product
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2115-2026·2026-05-13
Medline Tracheostomy Convenience Kits Sterilization Calibration Recall
Medline Industries is recalling certain tracheostomy convenience kits and related products due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
Category
Medical Device
Distribution
Distributed nationwide