The Recall Desk

State

Kentucky product recalls

73,096 recalls have nationwide distribution and so reach Kentucky. 7,194 additional recalls listed Kentucky specifically in their distribution scope.

What the numbers show

Total
7,194
Critical
1,409
Severe
1,706
Most recent
2026-09-23

Of the 7,194 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 1,706 (24%) are Severe.

These figures cover only the 7,194 recalls whose distribution notice names Kentucky specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8901–8925 of 80290

  • HighFDA (Devices)·Z-0595-2025·2024-12-11

    BACTEC 9120 System Recalled Due to Compromised Service Credentials

    BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.

    Product
    BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2025·2024-12-11

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits

    AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.

    Product
    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0089-2025·2024-12-11

    Array Liquid Antiseptic Handwash Recalled for Microbiological Test Failures

    Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.

    Product
    Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity

    Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0076-2025·2024-12-11

    Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide

    Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2025·2024-12-11

    Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity

    AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.

    Product
    Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2025·2024-12-11

    Spectral CT Devices Pose Collision and Misdiagnosis Software Risks

    Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.

    Product
    Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V923000·2024-12-11

    Suzuki Recalls 2023-2025 Burgman 400 Scooters for Fuel Leak Risk

    Suzuki is recalling 2023-2025 Burgman 400 scooters because a fuel supply hose may contact a vapor hose, causing fuel leaks that increase fire risk.

    Product
    SUZUKI — SUZUKI AN400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2025·2024-12-11

    Hollister CalciCare Calcium Alginate Dressing Recalled for Packaging Defect

    Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) due to defects in the primary packaging pouch that compromise sterile barrier integrity. The affected dressing was distributed nationwide to IL, TX, and VA.

    Product
    Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2025·2024-12-11

    Medline Tracheostomy Convenience Kits Recalled Due to Defective Component

    Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2025·2024-12-11

    Siemens Atellica CI Analyzer may produce falsely elevated electrolyte test results

    Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.

    Product
    Atellica CI Analyzer. Catalog Numbers: 10947347.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2025·2024-12-11

    Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component

    Medline is recalling L&D convenience kits distributed nationwide because they were manufactured with smoke evacuation pencils that Stryker subsequently recalled. The affected kits contain components from lot 23HMI048.

    Product
    MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0094-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits

    Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V921000·2024-12-11

    Gillig Recalls 2023 Low Floor Buses Due to Odometer Defect

    Gillig is recalling 2023 Low Floor diesel-hybrid transit buses because the odometer fails to display mileage in electric mode, potentially delaying critical maintenance.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2025·2024-12-11

    BD Bacterial Susceptibility Test Discs Recall for Decreased Potency

    Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.

    Product
    BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2025·2024-12-11

    Medline MaxOrb Extra Alginate Wound Dressing Recalled for Packaging Defect

    Advanced Medical Solutions is recalling 1,800 boxes of Medline MaxOrb Extra Alginate Wound Dressing due to defects in the primary packaging pouch that compromise sterile barrier integrity. Products affected were distributed in Illinois, Texas, and Virginia.

    Product
    MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component

    MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.

    Product
    MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2025·2024-12-11

    Sunitinib Malate Capsules Recalled Due to Label Mix-Up

    AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2025·2024-12-11

    MEDLINE Port Insertion Pack Recalled for Defective Component

    Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0628-2025·2024-12-11

    MEDLINE dental and oral surgery kits recalled due to defective component

    MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2025·2024-12-11

    Medline Convenience Kits Recalled Due to Defective Component

    Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.

    Product
    MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2025·2024-12-11

    Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity

    AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.

    Product
    Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2025·2024-12-11

    Medline Medical Device Kits Recalled Due to Defective SafeAir Component

    Medline is recalling 980 units of medical convenience kits manufactured using SafeAir Smoke Evacuation Pencil components that Stryker previously recalled. The kits were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2025·2024-12-11

    BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party

    BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.

    Product
    BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
    Category
    Medical Device
    Distribution
    Distributed nationwide