The Recall Desk

State

Kentucky product recalls

72,936 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.

These figures cover only the 7,164 recalls whose distribution notice names Kentucky specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3351–3375 of 80100

  • HighFDA (Devices)·Z-1260-2026·2026-02-11

    Menopause test cassettes recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units of the Menopause Test Cassette (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Menopause Test Cassette (Urine)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2026·2026-02-11

    Peripheral screws recalled after a lot was labeled the wrong length

    Tornier is recalling 427 Perform Reversed peripheral screws because a lot labeled 5.0mm x 18mm actually contains 5.00mm x 14mm screws.

    Product
    TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2026·2026-02-11

    Electrosurgical knives recalled over tip breakage from overheating and burning

    Olympus is recalling the Single Use Electrosurgical Knife KD-640L because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0472-2026·2026-02-11

    Passion fruit sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Passion Fruit flavour over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2026·2026-02-11

    Amyloid plasma controls recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and perso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0473-2026·2026-02-11

    Blue spirulina raspberry sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Blue Spirulina and Raspberry variety over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Blue Spirulina and Raspberry- UPC# 5065006235813
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2026·2026-02-11

    pTau 217 plasma cartridges recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2026·2026-02-11

    Susceptibility test cards recalled over false resistant antibiotic results

    bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.

    Product
    VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 42364
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2026·2026-02-11

    Electrosurgical knife KD-645 recalled over tip breakage during use

    Olympus is recalling 3,361 Single Use Electrosurgical Knife KD-645 units because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2026·2026-02-11

    Sample preparation systems recalled over a software dispensing error

    Beckman Coulter is recalling 50 CellMek SPS Sample Preparation Systems because a software error dispenses samples close to or touching tube bottoms, removing 60-100 microliters from the final sample.

    Product
    CellMek SPS Sample Preparation System, REF: C44603, with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0461-2026·2026-02-11

    Repackaged peanut candies recalled over undeclared milk, soy and peanut

    Beacon Promotions is recalling 541 units of repackaged M&Ms Peanut candies, 1.3 oz, over undeclared milk, soy and peanut allergens.

    Product
    Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1262-2026·2026-02-11

    Home male fertility tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Male Fertility Sperm Test for Home Use (Cassette)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2026·2026-02-11

    pTau 217 plasma calibrators recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 117 units of Lumipulse G pTau 217 Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2026·2026-02-11

    Backflush instruments recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2026·2026-02-11

    Scleral IOL markers recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2026·2026-02-11

    Plasma ratio test recalled over falsely elevated amyloid classification results

    Fujirebio Diagnostics is recalling 23 units of Lumipulse G pTau217/beta-Amyloid 1-42 Plasma Ratio because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2026·2026-02-11

    Surgical robots recalled over a software error hiding failed arm diagnostics

    Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.

    Product
    Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Food)·H-0476-2026·2026-02-11

    Mango pineapple sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Mango and Pineapple variety over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango and Pineapple- UPC# 5065006235301
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2026·2026-02-11

    Ketone and urinalysis strips recalled over missing premarket clearance

    Changchun Wancheng Bio-Electron is recalling 32,500 units covering The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0470-2026·2026-02-11

    Apple cinnamon sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Apple and Cinnamon flavour over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2026·2026-02-11

    Diamond dusted ILM elevators recalled over voids in pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
    Category
    Medical Device
    Distribution
    Distributed nationwide