The Recall Desk

State

Indiana product recalls

20,190 recalls have nationwide distribution and so reach Indiana. 0 additional recalls listed Indiana specifically in their distribution scope.

About recalls in Indiana

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Indiana consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

9451–9475 of 20190

  • HighFDA (Devices)·Z-1530-2024·2024-04-24

    Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

    Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

    Product
    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Potential Automatic Power Loss

    Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2024·2024-04-24

    Philips Ingenia MRI System Patient Support Table Floor Plate Installation Defect

    Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.

    Product
    Ingenia 1.5T S, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2024·2024-04-24

    MRI System Patient Support Table Floor Plate Installation Defect

    Philips Intera 1.0T MRI systems may have an incorrectly installed patient support table floor plate. This defect could affect patient safety during magnetic resonance imaging procedures.

    Product
    Intera 1.0T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2024·2024-04-24

    Philips MRI patient support table floor plate installation defect recall

    Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.

    Product
    Intera 1.5T Master/Nova, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2024·2024-04-24

    Fetal Membrane Rupture Test Kits Recalled for False Positive Results

    Actim PROM dipstik fetal membrane rupture test kits are recalled because personal lubricants can interfere with the test, producing false positive results.

    Product
    Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2024·2024-04-24

    Philips Achieva 1.5T MRI Systems Recalled Due to Incorrect Support Table Installation

    Philips is recalling 1,921 Achieva 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.

    Product
    Achieva 1.5T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2024·2024-04-24

    Philips Intera 0.5T MRI System Patient Table Floor Plate Installation Defect

    Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.

    Product
    Intera 0.5T Standard, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2024·2024-04-24

    Siemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results

    Siemens Atellica CH and CI analyzers may produce falsely elevated cholesterol and lipid test results (2–16% high) after iron tests. This affects clinical calibration, quality control checks, and patient test results.

    Product
    Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0446-2024·2024-04-24

    Thyroid pharmaceutical ingredient recalled for failed stability specifications

    Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.

    Product
    S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2024·2024-04-24

    Surgical and Cardiovascular Device Marketing Brochures Recalled for Documentation Errors

    Baxter Healthcare is recalling surgical and cardiovascular device marketing brochures that contain information conflicting with the official Instructions for Use. The inaccurate content could lead to incorrect device use.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter automatic power cycling may cause monitoring loss

    Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2024·2024-04-24

    Magnetic Resonance System Patient Support Table Floor Plate Installation Issue

    Philips is recalling the MR 7700 Magnetic Resonance System due to potential incorrect installation of the patient support table floor plate. The recall affects 26 units distributed worldwide.

    Product
    MR 7700, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2024·2024-04-24

    CryoValve SG Heart Valve Recalled for Staphylococcus aureus Contamination

    Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.

    Product
    CryoValve SG Cryopreserved Pulmonary Human Heart Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0445-2024·2024-04-24

    Eli Lilly Recalls Humalog Sterile Diluent Due to Manufacturing Deviations

    Eli Lilly & Company has voluntarily recalled 700 vials of Humalog sterile diluent due to Current Good Manufacturing Practice (CGMP) deviations. The affected batch (D608951C, exp. 4/10/2025) was distributed nationwide.

    Product
    HUMALOG — HUMALOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2024·2024-04-24

    Philips Achieva 3.0T MRI System Patient Support Table Floor Plate Installation Defect

    Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.

    Product
    Achieva 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2024·2024-04-24

    MRI system patient support table floor plate installation defect

    Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.

    Product
    SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0447-2024·2024-04-24

    Specialty Process Labs Recalls Thyroid USP Drug Ingredient for Failed Stability

    Specialty Process Labs is recalling Thyroid, USP, a pharmaceutical ingredient used in drug manufacturing, due to failed stability specifications. Seven lots distributed nationwide are affected.

    Product
    S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2024·2024-04-24

    MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.

    Product
    Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2024·2024-04-24

    SW Bari Lift & Transfer Device Recalled Due to Weight and Safety Defects

    Raye's Inc. is recalling the SW Bari Lift & Transfer (Model 38060000) due to two critical defects: it cannot safely support its maximum rated weight, and it lacks a safety mechanism to prevent falls during a single equipment failure.

    Product
    SW Bari Lift & Transfer, Model Number 38060000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2024·2024-04-24

    Cook Coons Taper Dilators recalled due to low packaging seal strength

    Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.

    Product
    Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.
    Category
    Medical Device
    Distribution
    Distributed nationwide