The Recall Desk

State

Indiana product recalls

73,104 recalls have nationwide distribution and so reach Indiana. 9,585 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,585
Critical
1,913
Severe
2,148
Most recent
2026-09-23

Of the 9,585 recalls naming Indiana we have scored against our rubric, 1,913 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,148 (22%) are Severe.

These figures cover only the 9,585 recalls whose distribution notice names Indiana specifically. The 73,104 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

12326–12350 of 82689

  • HighFDA (Devices)·Z-1723-2024·2024-05-08

    ZPLP Distal Lateral Fibular Plates: locking screws may not secure

    Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.

    Product
    ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2024·2024-05-08

    Zimmer Periarticular Locking Plate System Screw-Locking Defect Recall

    Zimmer is recalling Periarticular Locking Plate System Distal Lateral Fibular Plates due to threading defects that may prevent locking screws from properly mating. This could result in loss of fixation and need for additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2024·2024-05-08

    Battery Mobile X-ray Units Recalled for Anti-Fall System Interference

    SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING models worldwide due to potential interference with the anti-fall system.

    Product
    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2024·2024-05-08

    Lumbar Interbody Fusion Curette Recalled for Potential Blade Shearing

    Advanced Research Medical is recalling 1,150 units of its Lumbar Interbody Fusion System Flexible Curette Loop Blade because the disposable blade may shear during surgery, potentially leaving fragments within the shaft assembly. No injuries have been reported.

    Product
    ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2024·2024-05-08

    ZPLP Distal Lateral Fibular Plates Recalled for Defective Threading

    Zimmer surgical plates may have thread defects that prevent screws from properly locking, potentially causing loss of surgical fixation. Affected devices were distributed worldwide; healthcare providers should verify lot numbers against the FDA recall notice.

    Product
    ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2024·2024-05-08

    Zirconium oxide dental restoration blocks may develop cracks during sintering

    IVOCLAR VIVADENT recalls 12,525 zirconium oxide blocks for dental restorations after defective units may develop cracks during sintering, potentially causing restoration fractures.

    Product
    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2024·2024-05-08

    Zimmer Periarticular Locking Plate threading defect may compromise surgical fixation

    Zimmer's Periarticular Locking Plate System may have defective threads in locking holes, preventing secure screw mating. The defect could result in loss of surgical stability and require additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2024·2024-05-08

    RayStation radiation therapy planning software affected by source-to-surface distance calculation error

    RayStation radiation therapy treatment planning software versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 may calculate source-to-surface distance incorrectly, potentially affecting dose calculations. Approximately 5 units are distributed worldwide.

    Product
    RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2024·2024-05-08

    Zimmer Fibular Plate Recall: Locking Hole Thread Form Defect

    Zimmer is recalling certain ZPLP Distal Lateral Fibular Plates due to a thread form issue in the locking holes. Improperly mating screws may not correctly lock, potentially resulting in loss of fixation and need for additional surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1745-2024·2024-05-08

    Radiation therapy planning system dose calculation error

    RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were distributed worldwide.

    Product
    RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate Locking Screw Defect

    Zimmer's Periarticular Locking Plate may have defective locking holes that prevent screws from properly locking, risking loss of bone fixation and requiring additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2024·2024-05-08

    RayStation Radiation Therapy System Recalled for Potential Dosing Error

    RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.

    Product
    RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2024·2024-05-08

    Medtronic Invos Infant Sensor Cables recalled for manufacturing defects

    Covidien is recalling 1,122 Medtronic Invos Reusable Infant Sensor Adapter Cables due to manufacturing defects in connectors. The defects may cause error codes or non-functioning monitoring channels.

    Product
    Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1714-2024·2024-05-08

    Zimmer Locking Plate System recalled due to thread mating defect

    Zimmer is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect in the locking holes. Locking screws may not properly mate with the plate, potentially causing surgical delay or loss of fixation.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0477-2024·2024-05-08

    Methylergonovine Maleate tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.

    Product
    METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2024·2024-05-08

    Zimmer Fibular Plate Recall: Defective Locking Hole Threading

    Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to defective threading in the locking holes. The screws may not properly engage with the plate, potentially causing surgical delays or loss of bone fixation.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plates May Have Improper Screw Locking

    A thread form defect in the locking holes of Zimmer surgical bone plates may prevent locking screws from securing properly, potentially causing loss of fixation during surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2024·2024-05-08

    Zirconium Oxide Dental Blocks Recalled Due to Fracture Risk

    IVOCLAR VIVADENT AG is recalling 2,286 units of zirconium oxide blocks used for dental restorations because defective units may develop cracks during processing, potentially causing restorations to fracture in patients' mouths.

    Product
    IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2024·2024-05-08

    Zirconium Oxide Dental Restoration Blocks Recalled for Potential Cracking

    IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide dental blocks nationwide due to defective units that may crack during sintering and cause dental restoration fracture.

    Product
    IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2024·2024-05-08

    Radiation Therapy Planning System May Report Dose Values Too High

    RayStation radiation therapy planning software versions 9.0.0.113 and 9.0.1.142 may report dose values that are higher than actual. The Class II recall affects 63 units distributed worldwide.

    Product
    RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2024·2024-05-08

    Jackson-Pratt Drainage Kits Shipped Unsterilized in Voluntary Removal

    Cardinal Health is voluntarily removing Jackson-Pratt drainage kits (Lot 210751D6) that were shipped without sterilization. The unsterilized devices pose an infection risk if used in patient care.

    Product
    Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2024·2024-05-08

    Galaxy System Wired Controller Recalled for Unintended Scope Motion

    Noah Medical recalls 17 Galaxy System wired controllers (Model GAL-019) due to calibration misalignment that may cause unintended scope motion during bronchoscopic procedures.

    Product
    Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2024·2024-05-08

    Zimmer Periarticular Locking Plate screw-mating defect risks surgical fixation loss

    Zimmer's Periarticular Locking Plate System has a thread defect that may prevent proper screw locking, potentially causing loss of surgical fixation. Affected units distributed worldwide.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2024·2024-05-08

    Abbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk

    Abbott is recalling the Cholestech LDX Battery Kit due to a potential for battery swelling that could cause minor burns, cuts, abrasions, or electrical shock to users.

    Product
    Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
    Category
    Medical Device
    Distribution
    Distributed nationwide