The Recall Desk

State

Indiana product recalls

73,092 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 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

10026–10050 of 82677

  • HighFDA (Devices)·Z-3269-2024·2024-10-02

    Boston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach. The recall covers 176 units distributed worldwide.

    Product
    WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3224-2024·2024-10-02

    Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz Endoscopy is recalling 5 nephroscopes because their instructions for use list reprocessing methods not reviewed or approved by the FDA.

    Product
    Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2024·2024-10-02

    Philips MR 7700 MRI Scanner Recall for Loose Screws

    Philips is recalling 7 MR 7700 MRI scanners because loose screws may block the tabletop, potentially delaying diagnosis or causing patient anxiety.

    Product
    MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3288-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 15 units distributed worldwide.

    Product
    AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3301-2024·2024-10-02

    Cardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage

    Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve may break due to improper use. Labeling changes were made to address the issue.

    Product
    (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3294-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 10 units distributed worldwide.

    Product
    AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3281-2024·2024-10-02

    Boston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach during use.

    Product
    WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2024·2024-10-02

    American Contract Systems Recalls Open Shoulder Medical Convenience Kits

    American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.

    Product
    Open Shoulder, LWOS39L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2024·2024-10-02

    Custom Procedure Kit Sheath Introducers Mislabeled by Size

    Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.

    Product
    Custom Procedure Kit, REF: K12T-11077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3201-2024·2024-10-02

    Philips MR 5300 MRI System Recalled for Loose Assembly Screws

    Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.

    Product
    MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3217-2024·2024-10-02

    Siemens Diagnostic Ultrasound Systems Recalled for Incorrect Unit Conversion

    Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.

    Product
    ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3298-2024·2024-10-02

    Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration

    CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.

    Product
    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3245-2024·2024-10-02

    FDA Recalls Surgical Instrument Handle That May Break During Use

    The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.

    Product
    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3286-2024·2024-10-02

    WallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3258-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date

    Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3247-2024·2024-10-02

    BD Phoenix diagnostic systems may misidentify E. coli in clinical samples

    The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.

    Product
    BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3192-2024·2024-10-02

    Biopsy instrument packaging holes compromise sterile barrier integrity

    Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.

    Product
    BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3187-2024·2024-10-02

    Roche Creatine Kinase test reagents recalled for calibration errors

    Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.

    Product
    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3197-2024·2024-10-02

    MRI Device Ingenia Ambition S Screws May Loosen and Block Tabletop

    Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.

    Product
    Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3228-2024·2024-10-02

    Endovascular AAA Pack recalled for sterilization assurance failure

    American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.

    Product
    Endovascular AAA Pack, ESED52B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3242-2024·2024-10-02

    Nasal Sinus Pack Recalled Due to Sterilization Verification Failure

    American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.

    Product
    Nasal Sinus Pack, MTSN26B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3218-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions

    Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3215-2024·2024-10-02

    Siemens ACUSON Juniper ultrasound systems software unit conversion error

    Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.

    Product
    ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3285-2024·2024-10-02

    Esophageal Stent System Recalled Due to Potential Catheter Tip Detachment

    Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0664-2024·2024-10-02

    FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach

    AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.

    Product
    Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
    Category
    Drug
    Distribution
    Distributed nationwide