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.

8651–8675 of 82548

  • HighFDA (Drugs)·D-0174-2025·2025-01-08

    Injectable phenylephrine recalled due to defective tamper-evident seals nationwide

    Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.

    Product
    phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2025·2025-01-08

    Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination

    Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0172-2025·2025-01-08

    Dapsone Topical Gel Recalled Due to Crystallization Defect

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (2760 packs) distributed nationwide due to crystallization in the formulation. The voluntary recall affects lots T400514 and T400808.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2025·2025-01-08

    SynchroMed II and III implantable pumps recalled for software issues

    Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0173-2025·2025-01-08

    Ketamine injection syringes recalled due to missing tamper-evident seals

    Hikma Injectables is recalling 1,800 ketamine injection syringes nationwide because tamper-evident seals are not attached to several syringes, compromising sterility assurance.

    Product
    ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25V003000·2025-01-08

    Blue Bird Recalls 2024-2025 All American School Buses for Wiring Defect

    Blue Bird is recalling 2024-2025 All American school buses because incorrect wiring reverses high and low beams, potentially blinding other drivers.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V004000·2025-01-08

    Blue Bird Recalls 2025 All American Bus for Wiring Defect

    Blue Bird is recalling one 2025 All American transit bus because incorrect wiring reverses high and low beams, potentially blinding other drivers.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2025·2025-01-08

    Medline Nasal Pack Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline custom nasal pack procedure kits contain non-sterile surgical components with potential endotoxin contamination. Customers should discontinue use and contact Medline.

    Product
    Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled Due to Sterility Concerns

    Medline is recalling custom surgical procedure kits that contain non-sterile surgical supplies with potential for endotoxin contamination. The kits were distributed worldwide, including the United States, United Arab Emirates, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25088·2025-01-08

    Children's Bike Helmets Recalled for Failure to Meet Federal Safety Standards

    About 6,500 Wemfg children's bike helmets sold on Amazon fail to comply with federal safety standards for impact protection and stability. The helmets can fail to protect in crashes, posing a risk of head injury.

    Product
    Wemfg Children's Multi-Purpose Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2025·2025-01-08

    Medline MICRODISECTOMY PACK recalled for endotoxin contamination

    Medline custom MICRODISECTOMY PACK kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination are being recalled. Approximately 1,494 units were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2025·2025-01-08

    Medline surgical procedure kits recalled for non-sterile supplies

    Medline is recalling custom medical procedure kits containing non-sterile surgical supplies with potential endotoxin contamination. The affected kits were distributed nationwide and internationally.

    Product
    Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2025·2025-01-08

    Baxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter is recalling SIGMA Spectrum Infusion Pump (Version 6) units that were released after repair without complete flow testing. The incomplete testing poses a risk of improper device operation.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2025·2025-01-08

    3M Unitek Orthodontic Primer Recalled Due to Bond Failures and Skin Irritation

    3M Unitek is recalling Transbond Plus Self-Etching Primer used in orthodontic bonding due to reports of bracket bond failures and skin irritation or blistering.

    Product
    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Endotoxin Contamination Risk

    Medline Industries is recalling 2344 custom surgical kits with non-sterile components that may contain endotoxins. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2025·2025-01-08

    Medtronic Implantable Drug Pumps Recalled for Software Defects

    Medtronic has recalled 566 SynchroMed II and III implantable drug infusion pumps due to software issues in the controlling application. No injuries or illnesses have been reported.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01082025-01·2025-01-08

    Chicken Curry Empanadas Recalled For Undeclared Milk Allergen

    USDA FSIS issued a public health alert for Chicken Curry Empanadas that may contain undeclared milk. Consumers with milk allergies should not consume these products.

    Product
    Rajbhog Foods (NJ), Inc. — FSIS Issues Public Health Alert For Chicken Empanada Products Due To Misbranding And Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0365-2025·2025-01-08

    Sam's Club Hatch Chile Chicken Enchiladas Recalled for Listeria

    Sam's Club is recalling Member's Mark Hatch Chile Chicken Enchiladas because the product may contain Listeria monocytogenes.

    Product
    Member's Mark Hatch Chile Chicken Enchiladas, ready to cook, perishable, packaging type: aluminum/black oven-safe tray Net wt. variable - average 1.52 lbs. UPC 00226529000004, UPC 00409802813793
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2025·2025-01-08

    Medline surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline is recalling 474,300 custom surgical procedure kits because they contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. These components could pose infection risks during surgical procedures.

    Product
    Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2025·2025-01-08

    SynchroMed II and III Implantable Pumps Recalled for Software Issues

    Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2025·2025-01-08

    Medline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline Industries is recalling custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 1,072 units were distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
    Category
    Medical Device
    Distribution
    Distributed nationwide