The Recall Desk

State

Indiana product recalls

72,992 recalls have nationwide distribution and so reach Indiana. 9,556 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,556
Critical
1,903
Severe
2,136
Most recent
2026-09-16

Of the 9,556 recalls naming Indiana we have scored against our rubric, 1,903 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,136 (22%) are Severe.

These figures cover only the 9,556 recalls whose distribution notice names Indiana specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8701–8725 of 82548

  • HighFDA (Devices)·Z-0738-2025·2025-01-01

    Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error

    Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0317-2025·2025-01-01

    BORSARI Bloody Mary Mix Recalled for Undeclared Fish and Soy Allergens

    Borsari Food Company Inc is recalling BORSARI Bloody Mary Mix (32 fl. oz.) due to undeclared fish (anchovy) and soy. The product was distributed across multiple states, and consumers should not consume it.

    Product
    BORSARI Food Company Incorporated; BLOODY MARY MIX ; 32 FL. OZ; INGREDIENTS: Tomato juice, corn syrup, non-fat milk solids, orange juice, lemon juice, lime juice, cayenne pepper, vinegar, salt, garlic powder, Worcestershire sauce, prepared horseradish, maltic acid, sodium and pot
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0759-2025·2025-01-01

    Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk

    Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.

    Product
    ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays

    Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2025·2025-01-01

    Siemens magnesium reagent cartridges recalled for false measurement results

    Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.

    Product
    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2025·2025-01-01

    Blood Analysis System Software Error Can Assign Wrong Patient Name

    Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2025·2025-01-01

    Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination

    Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply May Fail During Use

    BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.

    Product
    Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2025·2025-01-01

    RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall

    Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.

    Product
    RUMMELL, Medline Item No. ST006ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2025·2025-01-01

    Galaxy System bronchoscope power supply defect may injure lung tissue

    Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.

    Product
    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0731-2025·2025-01-01

    Abbott Vascular inflation device may leak during cardiovascular procedures

    Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0736-2025·2025-01-01

    Siemens epoc Blood Analysis System Recalled for Patient Identification Software Error

    Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0159-2025·2025-01-01

    Prescription chlorpromazine tablets recalled due to manufacturing quality defect

    Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2025·2025-01-01

    Daytona Small Stature Locking Caps recalled for manufacturing defects

    SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.

    Product
    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2025·2025-01-01

    Medline surgical patties and strips recalled for endotoxin contamination

    Medline surgical patties and strips used in certain procedure convenience kits were found to contain higher-than-expected endotoxin levels that may exceed safety specifications. The affected kits were distributed nationwide and in Canada.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0158-2025·2025-01-01

    Duloxetine Delayed-Release Capsules Recalled Nationwide for Excess N-Nitroso Impurity

    Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity above recommended limits. The affected product was distributed nationwide in 1,815 bottles with two specific lot numbers and expiration dates.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2025·2025-01-01

    Blood Analysis System Recalled Due to Patient Name Assignment Software Error

    Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2025·2025-01-01

    Medline Surgical Needle Holders Recalled for Sterility Compromise

    Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.

    Product
    ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2025·2025-01-01

    Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals

    Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.

    Product
    ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0162-2025·2025-01-01

    Duloxetine antidepressant recall for chemical impurity above FDA limit

    Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2025·2025-01-01

    Duloxetine 30mg Capsules Recalled Due to Nitrosamine Impurity

    Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2025·2025-01-01

    Blood analyzer system recalled for patient name assignment software error

    Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or mistreatment.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2025·2025-01-01

    Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk

    Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.

    Product
    STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2025·2025-01-01

    Medline Surgical Scissors Recalled for Sterility Seal Defect

    Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.

    Product
    O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide