State

Kentucky product recalls

72,992 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 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7826–7850 of 80157

HighFDA (Devices)·Z-1193-2025·2025-02-26
RayStation radiation therapy software recall for density calculation inconsistency
RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1197-2025·2025-02-26
Hot Dog Patient Warming Mattress Connector Cable Deflection Recall
Augustine Temperature Management is recalling 4 units of the Hot Dog Patient Warming Mattress due to connector cable deflection that causes intermittent connection failures after approximately one year of use.
Product
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2025·2025-02-26
Dexcom G6 Glucose Monitoring System Receiver May Fail to Deliver Critical Alarms
The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.
Product
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0235-2025·2025-02-26
Atomoxetine Capsules Recalled Due to Excess N-Nitroso Impurity
Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. The nationwide recall affects 80,160 bottles.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0237-2025·2025-02-26
Atomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling 39,168 bottles of Atomoxetine 100 mg capsules nationwide due to manufacturing deviations that resulted in N-Nitroso impurity exceeding FDA recommended limits. No illnesses have been reported.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2025·2025-02-26
Patient Warming Mattress Connector Cable Intermittent Connection Defect
Augustine Temperature Management is recalling Hot Dog Patient Warming Mattresses due to connector cable defects that may cause intermittent electrical connection after extended use, potentially affecting the device's heating function.
Product
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0233-2025·2025-02-26
Prescription Atomoxetine capsules recalled for N-Nitroso impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0232-2025·2025-02-26
Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0566-2025·2025-02-26
Feel Good Foods Three Cheese Mac & Cheese Bites recalled due to metal pieces
Feel Good Foods Three Cheese Mac & Cheese Bites are being recalled nationwide due to the presence of metal pieces in the frozen product. Metal fragments pose a potential choking or injury hazard.
Product
Feel Good Foods; Three Cheese Mac & Cheese Bites; NET WT 8oz (224g); packaged in yellow carton; 9 units per case; Frozen; UPC: 89903900280-8
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1201-2025·2025-02-26
remel Blood Agar EMB Agar Biplate Recalled for Listeria Contamination
Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.
Product
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1203-2025·2025-02-26
Dexcom G6 glucose receiver may fail to deliver high or low alarms
Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.
Product
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0227-2025·2025-02-26
Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications
The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.
Product
LORAZEPAM — LORAZEPAM (LORAZEPAM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1190-2025·2025-02-26
RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning
RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0244-2025·2025-02-26
Atomoxetine Prescription Capsules Recalled for Impurity Above FDA Recommended Level
Glenmark Pharmaceuticals is recalling 58,368 bottles of Atomoxetine Capsules 100 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. The recall affects bottles distributed nationwide.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2025·2025-02-26
Dexcom G6 Glucose Monitor May Fail to Deliver Alarms Properly
Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.
Product
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0236-2025·2025-02-26
Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination
Glenmark Pharmaceuticals is recalling 87,600 bottles of Atomoxetine 80 mg capsules nationwide due to N-Nitroso Atomoxetine impurity detected above FDA-recommended limits. Consult your healthcare provider if affected.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1180-2025·2025-02-26
Endotracheal Tube Fastener Recalled for Decreased Skin Barrier Wear
Hollister is recalling AnchorFast Oral Endotracheal Tube Fasteners due to reports of decreased skin barrier wear time, which could lead to tube migration. The recall affects approximately 366,324 units distributed in the US and Canada.
Product
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1188-2025·2025-02-26
Medical Device RayStation Dosage Calculation Inconsistency in Radiation Therapy Planning
RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1179-2025·2025-02-26
Endotracheal Tube Fastener Recalled for Potential Tube Migration Risk
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
Product
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1187-2025·2025-02-26
RayStation radiation therapy planning software density uncertainty calculation inconsistency
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment plans.
Product
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0240-2025·2025-02-26
Prescription Drug Recall: Atomoxetine Capsules Due to Impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1200-2025·2025-02-26
Medical Diagnostic Culture Media Recalled for Listeria Contamination
Remel, Inc recalls blood agar culture media used in diagnostic laboratories for potential Listeria monocytogenes contamination. The affected lot was distributed nationwide.
Product
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1176-2025·2025-02-26
3M V.A.C. VIA Negative Pressure Wound Therapy System Recalled for Leak Alarm Malfunctions
KCI USA is recalling approximately 2,169 units of the 3M V.A.C. VIA negative pressure wound therapy system due to increased complaints about leak alarm malfunctions affecting certain units.
Product
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1184-2025·2025-02-26
LIFEPAK 15 Monitor Software Error Disables Sensor Monitoring
Physio-Control is recalling 622 LIFEPAK 15 V4 monitors due to a software error that prevents monitoring of carboxyhemoglobin and methemoglobin saturation levels in affected sensors.
Product
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1191-2025·2025-02-26
RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency
RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
Category
Medical Device
Distribution
Distributed nationwide