State

Kentucky product recalls

73,570 recalls have nationwide distribution and so reach Kentucky. 7,203 additional recalls listed Kentucky specifically in their distribution scope.

What the numbers show

Total: 7,203
Critical: 1,409
Severe: 2,024
Most recent: 2026-10-21

Of the 7,203 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 7,203 recalls whose distribution notice names Kentucky specifically. The 73,570 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

25801–25825 of 80773

HighFDA (Food)·F-0878-2021·2021-09-01
Gordon Choice Deli Style Tuna Salad Recalled for Undeclared Wheat
RMH Foods is recalling Gordon Choice Deli Style Tuna Salad (4 lb. containers) due to labeling errors that may expose consumers to undeclared wheat and tuna allergens. The product was distributed to Gordon Food Service retail stores and food service establishments across multiple states.
Product
Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb. retail unit, 2 4 Lb. retail units per wholesale case. Wholesale case labeled as Deli Style Tuna Salad The recalled product contains tuna salad, but it has two labels. The bottom container states Deli Style Chicken…
Category
Food
Distribution
13 states
HighFDA (Devices)·Z-2340-2021·2021-09-01
Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide
W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.
Product
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2355-2021·2021-09-01
HARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk
Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.
Product
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2342-2021·2021-09-01
Philips Ingenia MRI System recalled due to incorrect pressure relief valve
Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause injury.
Product
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2021·2021-09-01
MRI System Table Pads Missing Required Natural Rubber Allergen Label
Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.
Product
ECHELON Oval MRI System
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21193·2021-09-01
TurboSke Kids Toddler Bike Helmets Recalled for Head Injury Risk
SKE Outdoors is recalling about 860 TurboSke Kids Toddler Bike Helmets (size small) because they do not meet U.S. CPSC federal safety standards, posing a risk of head injury. No injuries have been reported.
Product
TurboSke Kids Toddler Bike Helmets
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·21V682000·2021-09-01
Volvo Recalls Vehicles Due to Seat Belt Retractions Deactivating Early
Volvo is recalling specific 2021-2022 models because seat belt retractors may deactivate early, preventing child restraints from securing properly.
Product
VOLVO — VOLVO V60CC, V90, V90CC, XC60
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2021·2021-09-01
MRI System Pressure Relief Valve Installation Error May Release Helium Gas
Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.
Product
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Cause Helium Release
Philips Achieva 3.0T MRI systems may have an incorrectly installed pressure relief valve that could release helium gas and cause injury. Affected units are distributed in the United States and internationally.
Product
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2021·2021-09-01
FDA Recalls AltiVate Shoulder Implant System Due to Component Mating Failure
The FDA is recalling AltiVate Anatomic Shoulder Systems due to humeral stem components that may fail to mate properly with broach handles, potentially delaying surgery or requiring revision.
Product
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-2349-2021·2021-09-01
Vascular Ultrasound Examination Table Recalled for Weld Failure
Oakworks vascular ultrasound examination tables (models USV1 and USV2) are recalled due to potential weld failure in the tilting mechanism bracket. A failed weld could prevent the table from tilting, affecting patient positioning.
Product
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2021·2021-09-01
ECHELON MRI System Recalled for Missing Natural Rubber Allergen Labeling
Hitachi Healthcare Americas is recalling ECHELON MRI System table pads because packaging and user manuals lack required disclosure that the pads contain dry natural rubber, a potential allergen. No illnesses have been reported.
Product
ECHELON MRI System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2021·2021-09-01
AQUABEAM Handpiece scope tube tip may detach during procedures
PROCEPT BIOROBOTICS is recalling AQUABEAM Handpieces (model HP2000) because the scope tube tip may detach during use, potentially requiring procedural delay or additional intervention to remove the tip from the bladder or prostate.
Product
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2356-2021·2021-09-01
Surgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk
Ethicon is recalling HARMONICHD 1000i Shears due to a cracked internal component that may cause continuous device activation and result in burns. About 68,960 units have been distributed worldwide.
Product
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V683000·2021-09-01
Polestar Recalls 2021 Polestar 1 Vehicles for Seat Belt Retractions
Polestar is recalling 2021 Polestar 1 vehicles because seat belt retractors may deactivate early, preventing child restraints from securing properly.
Product
POLESTAR — POLESTAR POLESTAR 1
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2021·2021-09-01
Accu-Chek Performa Test Strips Recalled Due to Defective Packaging
Roche Diabetes Care is recalling Accu-Chek Performa test strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to inappropriate diabetes treatment decisions.
Product
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2339-2021·2021-09-01
OASIS MRI table pads recalled for missing latex allergen labeling
Hitachi Healthcare Americas has recalled OASIS MRI System table pads due to missing labels and user manual notification about dry natural rubber content. The missing notification violates federal labeling requirements for this latex allergen.
Product
OASIS MRI System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0758-2021·2021-09-01
PVP Iodine Prep Pads Recalled for Subpotent Active Ingredient
Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0756-2021·2021-09-01
Micafungin for Injection Recalled for Incomplete Package Insert
Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
Product
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0757-2021·2021-09-01
Micafungin for Injection recalled for incomplete package insert
Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.
Product
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0766-2021·2021-09-01
Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.
Product
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0761-2021·2021-09-01
PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0763-2021·2021-09-01
PDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.
Product
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0759-2021·2021-09-01
PDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient
Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0764-2021·2021-09-01
PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency
Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.
Product
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC…
Category
Drug
Distribution
Distributed nationwide