The Recall Desk

State

Kentucky product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4701–4725 of 80104

  • HighFDA (Devices)·Z-0321-2026·2025-11-05

    Surgical imaging software recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2026·2025-11-05

    Chemotherapy vial adapters recalled because port weld may separate and leak

    ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2026·2025-11-05

    Testosterone and triamcinolone 50 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 64,924 sterile Testosterone / Triamcinolone Acetonide 50MG/10MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2026·2025-11-05

    Pyxis Medbank units recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 8,262 BD Pyxis Medbank units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2026·2025-11-05

    Magseed Pro 12 cm markers recalled over potential cotton fiber contamination

    Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2026·2025-11-05

    Entry system accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2026·2025-11-05

    Controlled substance safe towers recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 443 BD Pyxis CII Safe ES Tower Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2026·2025-11-05

    Oncology kits with ChemoLock port recalled over port weld separation

    ICU Medical is recalling 150 Oncology Kits with ChemoLock and ChemoLock Port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2026·2025-11-05

    Surgical navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 17 units of its Surgical Navigation Advanced Platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2026·2025-11-05

    ChemosafeLock bag spikes recalled over port weld separation risk

    ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0122-2026·2025-11-05

    Sting relief swabs recalled from one lot over a product mix-up

    Acme United Corporation is recalling 2,338 boxes of First Aid Only Sting Relief Swabs from one lot over a product mix-up.

    Product
    Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0147-2026·2025-11-05

    Lisdexamfetamine capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 40 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0411-2026·2025-11-05

    Ophthalmic knife suction sets recalled over residue on internal springs

    MicroSurgical Technology is recalling eight MST ArcDUO 9mm ophthalmic knives because springs in the accompanying suction set carry an unidentified residue that may cause eye irritation.

    Product
    MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0395-2026·2025-11-05

    Refill three month trial tampon boxes recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Trial Tampon Box because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0139-2026·2025-11-05

    Everolimus tablets recalled after an out of specification impurity result

    Endo USA is recalling 6,655 cartons of Everolimus tablets 5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2026·2025-11-05

    Refill tampon packs recalled because the product lacks 510k clearance

    Daye is recalling 3,074 packs of Refill 36 Coated Regular Tampons because the product lacks 510(k) clearance.

    Product
    Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2026·2025-11-05

    Refill three month heavy flow bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Heavy Flow Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0385-2026·2025-11-05

    Coated and nude super tampon packs recalled over missing 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Super and 9 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2026·2025-11-05

    Refill coated super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2026·2025-11-05

    Refill coated and nude super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
    Category
    Medical Device
    Distribution
    Distributed nationwide