The Recall Desk

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.

7101–7125 of 80157

  • SevereFDA (Devices)·Z-1526-2025·2025-04-23

    Ballard Closed Suction Catheters recalled due to sterility assurance failure

    Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1528-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for sterility assurance defect

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 22714183-5) due to lack of sterility assurance. The affected lot was distributed nationwide and internationally.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1570-2025·2025-04-23

    HeartMate Mobile Power Unit electrical malfunction may cause loss of power

    Thoratec LLC is recalling HeartMate Mobile Power Units due to an electrical component defect that may prevent the unit from turning on, cause unprompted shut down, or trigger false alarms. If power is lost and not switched to rechargeable batteries within 15 minutes, the connected pump may lose power.

    Product
    HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling sterile convenience kits with select breather pouches that may have open or weak seals, potentially compromising sterility. Affected units were distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Refer to RES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling multiple sterile convenience kits used for obstetric and gynecological procedures due to potential weak or open seals on breather pouches, which could compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2025·2025-04-23

    Medline pacemaker drape pack convenience kits recalled for seal defects

    Medline is recalling its Custom Pacemaker Drape Pack (Model DYNJCD0339) due to potential weak or open seals on breather pouches used in sterile convenience kits.

    Product
    Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2025·2025-04-23

    Philips DXR System DuraDiagnost Rel. 4 X-Ray System Collimator Fall Risk

    Philips is recalling 83 units of the DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to potential for the collimator to fall if incorrectly installed. The defect could pose injury risk to patients or staff.

    Product
    Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2025·2025-04-23

    Guide Wire with Ruler Tube metal ring detachment recall

    Stryker GmbH is recalling Guide Wire with Ruler Tube 3x1000 mm DIA devices because the metal ring at the end may detach during surgery.

    Product
    Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2025·2025-04-23

    TLX/TLC SP Guided Implant Driver missing laser marked depth markings

    Straumann USA LLC is recalling TLX/TLC SP Guided Implant Driver units because they are missing laser marked depth markings, which may affect proper surgical placement.

    Product
    TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2025·2025-04-23

    Medline sterile convenience kits recalled for potentially weak packaging seals

    Medline is recalling three sterile convenience kit models due to potentially open or weak seals on the breather pouches used for packaging. The affected kits are distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2025·2025-04-23

    Rover Mobile X-ray System MXU-RV35 Early X-ray Tube Failure Risk

    Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to the potential for early X-ray tube failure caused by excessive thermal load on the anode. The affected units were distributed nationwide in California, New Jersey, and Puerto Rico.

    Product
    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling multiple sterile surgical convenience kits due to potential open or weak seals on the breather pouches used for packaging. The compromised seals could affect product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1555-2025·2025-04-23

    GE Venue Go Ultrasound Systems Battery Risk Recall

    GE Medical Systems is recalling certain Venue Go ultrasound system models worldwide due to potential battery internal failure that could result in smoke or fire.

    Product
    Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2025·2025-04-23

    Abbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk

    Abbott Medical is recalling specific Aveir DR Leadless Pacemaker devices due to manufacturing exposure to higher-than-normal temperatures that may cause premature battery failure.

    Product
    Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2025·2025-04-23

    Medline Sterile Ophthalmic Convenience Kits Recalled for Weak Breather Pouches

    Medline Industries is recalling select sterile ophthalmic convenience kits due to potential open or weak seals on breather pouches used for packaging. The kits are used for various eye procedures.

    Product
    Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2025·2025-04-23

    Philips DXR System X-Ray Equipment Collimator Fall Hazard Recall

    Philips is recalling certain DXR System DuraDiagnost 4.1 stationary X-ray systems due to a potential for the collimator to fall if installed incorrectly.

    Product
    Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2025·2025-04-23

    Medline sterile convenience kits recalled for weak breather pouch seals

    Medline is recalling two models of sterile convenience kits (PAIN PACK and PAIN TRIAL PACK) due to potential open or weak seals on breather pouches used in the packaging.

    Product
    Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling sterile convenience kits for various medical procedures due to potential open or weak seals on breather pouches used in product packaging.

    Product
    Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2025·2025-04-23

    Guide Wire with Ruler Tube 3x800 mm Metal Ring Detachment Recall

    Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA because the metal ring at the end may detach during surgery. The defect could interfere with the surgical procedure.

    Product
    Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2025·2025-04-23

    Medline Convenience Kits for Obstetrical Procedures Recalled for Weak Seals

    Medline Industries is recalling 21,935 units of sterile convenience kits used for labor, delivery, and vaginal delivery procedures due to potential open or weak seals on breather pouches. The defective packaging could compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2025·2025-04-23

    Medline Intubation Tray Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling select Intubation Tray convenience kits (Model MNS10395, Lot 24KBI045) due to potential open or weak seals on breather pouches used for packaging. Weak seals may compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2025·2025-04-23

    Medline dental convenience kits recalled for potential weak seal packaging

    Medline is recalling five models of dental convenience kits due to the potential for open or weak seals on the breather pouches used for packaging. The affected sterile kits were distributed nationwide in the US and internationally.

    Product
    Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0713-2025·2025-04-23

    Tony's Chocolonely Everything Bar recalled for foreign objects

    Tony's Chocolonely Inc is recalling Tony's Chocolonely Everything Bar products nationwide due to the presence of stones in the chocolate bars.

    Product
    Tony's Chocolonely Everything Bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Open Breather Pouch Seals

    Medline Industries is recalling select sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) due to potential open or weak seals on breather pouches used for packaging. Compromised seals may affect product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2025·2025-04-23

    BD Pyxis MedBank Receiving Cabinet Software Medication Dispensing Safety Issue

    CareFusion 303 is recalling certain BD Pyxis MedBank Receiving Cabinet Software versions because a "Clear All" function may bypass pharmacist validation, potentially allowing incorrect medication dispensing without authorization.

    Product
    MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1F
    Category
    Medical Device
    Distribution
    Distributed nationwide