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.

10426–10450 of 82677

  • HighFDA (Devices)·Z-2829-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes

    BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2898-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 123 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2024·2024-09-04

    Stryker iBur 3.0mm surgical burr recalled over thermal hazard

    Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2024·2024-09-04

    Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk

    Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.

    Product
    Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2720-2024·2024-09-04

    Medical Device: Ion Endoluminal System Recalled for Instrument Arm Screw Failure

    Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.

    Product
    Ion Endoluminal System, REF: 380748-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2024·2024-09-04

    Immunoassay analyzer software may delay test processing with automation systems

    A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2941-2024·2024-09-04

    FRT250 Telescopic Implant Cartridge Recalled for Component Substitution

    OrthoPediatrics Canada is recalling FRT250 cartridges used in the Fassier-Duval Telescopic IM System because an incorrect component was substituted during assembly.

    Product
    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2024·2024-09-04

    Stryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk

    Stryker recalls iBur 3.0mm Precision Round surgical burs due to potential for excessive temperatures where the bur shank meets the bushing. Thermal injury risk may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2024·2024-09-04

    Stryker iBur surgical bur recalled for potential overheating at junction

    Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.

    Product
    Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2839-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes that are subject to a manufacturer recall. A total of 103 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2024·2024-09-04

    Stryker iBur Diamond Round surgical bur recalled for thermal overheating risk

    Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.

    Product
    Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2024·2024-09-04

    Stryker iBur 2.0mm Diamond Round Burr Thermal Hazard Recall

    Stryker recalled 1,226 iBur surgical burrs with multiple lot numbers worldwide due to potential overheating at the bur-shank connection point, which could cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2725-2024·2024-09-04

    Stryker surgical bur may overheat and cause thermal tissue damage

    Stryker iBur surgical burs may overheat during use in neurosurgery and spine surgery, potentially causing thermal tissue damage requiring medical intervention. Approximately 2,507 units were distributed worldwide.

    Product
    Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2024·2024-09-04

    Nanoplasty 3D Bunion Implant System Recalled for Mechanical Failure Risk

    Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.

    Product
    Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0644-2024·2024-09-04

    Prescription Ibuprofen Recalled Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2838-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M brand syringes due to manufacturer's voluntary recall. 130 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2875-2024·2024-09-04

    Beaver Visitec Recalls CustomEyes Procedure Packs with Sol-M Syringes

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M. Approximately 1,338 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2860-2024·2024-09-04

    Syringes in BVI CustomEyes Procedure Packs Recalled Nationwide

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The specific reason for the recall is not detailed in the FDA notice.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2876-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs nationwide containing syringes from Sol-Millennium Medical's voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2865-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by the syringe manufacturer. The affected packs have been distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001380;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2884-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 58001554) due to manufacturing concerns with the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001554;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2737-2024·2024-09-04

    BrainFeedback Pro 2 neurofeedback device recalled for missing design documentation

    RONAN MEDICAL LLC is recalling BrainFeedback Pro 2 neurofeedback devices due to missing design and development documentation. Devices may not perform as intended.

    Product
    BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2826-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000803;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2847-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary recall by the syringe manufacturer. The recall affects 43 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;
    Category
    Medical Device
    Distribution
    Distributed nationwide