The Recall Desk

State

Indiana product recalls

73,198 recalls have nationwide distribution and so reach Indiana. 9,587 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,587
Critical
1,913
Severe
2,149
Most recent
2026-09-30

Of the 9,587 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 2,149 (22%) are Severe.

Which agencies issued them

These figures cover only the 9,587 recalls whose distribution notice names Indiana specifically. The 73,198 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

15751–15775 of 82785

  • HighFDA (Devices)·Z-2393-2023·2023-08-16

    Ellacor System recalled for bearing adhesive defect risk

    The FDA is recalling 127 Ellacor System devices for a potential bearing adhesive failure in the handpiece. The defect could cause core overlap, leading to prolonged healing and scarring.

    Product
    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2023·2023-08-16

    Siemens ARTIS Icono Biplane Angiography Systems Thermal Cable Connector Defect

    Siemens recalls ARTIS icono biplane angiography systems with defective cable connectors that may cause thermal overload, burning smell, and loss of imaging functionality during clinical procedures.

    Product
    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2023·2023-08-16

    Olympus VISERA Tracheal Videoscope reprocessor compatibility and sterilization procedure revision

    Olympus is revising labeling for the VISERA Tracheal Intubation Videoscope to correct equipment compatibility information and update sterilization procedures. The device is no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors; sterilization and cleaning procedures have changed significantly.

    Product
    VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2023·2023-08-16

    VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells

    ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2023·2023-08-16

    Hip stem trial instruments recalled due to excessive removal force

    LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2360-2023·2023-08-16

    Angiography systems recalled due to thermal overload in cable connectors

    Siemens ARTIS icono floor angiography systems may experience thermal overload in cable connectors during fluoroscopy, causing burning smell and loss of imaging capability. The recall affects 7 units worldwide.

    Product
    ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2023·2023-08-16

    Philips MR 7700 Magnetic Resonance System Smoke Detector Interlock Bypass

    Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.

    Product
    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2023·2023-08-16

    Randox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk

    FDA recalls Randox RX Series Urea test kits because carryover from prior LDL-cholesterol tests may produce falsely low results, up to 11% below accurate values, potentially delaying diagnosis.

    Product
    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2023·2023-08-16

    Olympus OER-Pro Endoscope Reprocessor Revised Labeling for Equipment Compatibility

    Olympus revised OER-Pro labeling because two endoscope models (LF-V, LF-P) are no longer compatible. Sterilization parameters and cleaning procedures have also changed.

    Product
    Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2364-2023·2023-08-16

    Medical Device Recall: UroLift Visual Obturator Weld Defect Risk

    The UroLift Visual Obturator has an improperly performed weld that may fracture during use, and the welded area can harbor contamination not removed by standard cleaning. Affected units should not be used.

    Product
    UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2395-2023·2023-08-16

    MR Imaging System Smoke Detector Interlock Vulnerable to Bypass via Power Cycling

    Philips Ingenia Elition X MR systems can have their smoke detection safety interlock bypassed by power cycling the equipment. This vulnerability could allow unsafe operation during hazardous conditions.

    Product
    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2023·2023-08-16

    Ingenia Elition S MR System smoke detection interlock vulnerable to operator bypass

    Philips Ingenia Elition S MR systems can be circumvented by power cycling to bypass the smoke detection safety interlock that locks after smoke is detected. This could allow continued operation despite fire hazards.

    Product
    Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2023·2023-08-16

    Siemens ARTIS Angiography Systems: Thermal Overload Risk in Cable Connectors

    Siemens has recalled 10 ARTIS angiography systems due to thermal overload hazard in cable connectors. The issue may cause burning smell and loss of imaging functionality, potentially requiring treatment cancellation or system replacement.

    Product
    ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2023·2023-08-16

    Medical Device Recall: LINK MP Hip Stem Trial Instruments Removal Difficulty Risk

    Waldemar Link GmbH recalls LINK MP Monoblock hip stem trial instruments due to increased removal force requirements after impaction, which may prolong surgery or require procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2346-2023·2023-08-16

    LINK MP Monoblock Hip Stem trial instruments recalled for difficulty in removal

    Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2358-2023·2023-08-16

    FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives

    Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Calibrators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2349-2023·2023-08-16

    Hip Stem Trial Instrument Difficult to Remove After Impaction

    LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2363-2023·2023-08-16

    Surgical Spinal Tap Device Recalled for Incorrect Laser Marking

    Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.

    Product
    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2343-2023·2023-08-16

    Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility

    Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.

    Product
    Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2023·2023-08-16

    Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity

    Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2392-2023·2023-08-16

    Canon Medical INFX-8000C Tableside Console PWB Requires Replacement

    Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.

    Product
    INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2400-2023·2023-08-16

    MR 7700 Magnetic Resonance System Diagnostic Cable Installation Defect

    Philips MR 7700 Magnetic Resonance systems may have an improperly installed diagnostic cable. The cable does not impact system functionality or patient safety.

    Product
    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2353-2023·2023-08-16

    LINK MP Hip Stem Difficult to Remove After Surgical Implantation

    Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2399-2023·2023-08-16

    MRI System Cable Installation Issue During Service Setup

    Philips Ingenia Elition S MR systems may have an improperly installed cable connecting the SmokeDetector Interlock to the host PC. This affects service diagnostics only and does not impact system functionality.

    Product
    Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide