The Recall Desk

State

Indiana product recalls

73,376 recalls have nationwide distribution and so reach Indiana. 9,587 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,587
Critical
1,913
Severe
2,528
Most recent
2026-09-30

Of the 9,587 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 2,528 (26%) are Severe.

These figures cover only the 9,587 recalls whose distribution notice names Indiana specifically. The 73,376 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

20076–20100 of 82963

  • SevereFDA (Devices)·Z-0223-2023·2022-11-16

    Neonatal Endotracheal Tube Grip with Detachable Metal Clips Recalled

    CooperSurgical is recalling NEO-fit Neonatal Endotracheal Tube Grips due to metal clips that can become loose or detach. Eleven complaints include three cases of clip ingestion, three removals from the mouth, and one throat laceration.

    Product
    NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0146-2023·2022-11-16

    Hammond's Salted Caramel Cookies Recalled for Undeclared Peanut Allergen

    Hammond's Salted Caramel Cookies contain an undeclared peanut allergen due to mispacking of Peanut Butter Chocolate Chip Cookies into Salted Caramel boxes. Nationwide distribution affected.

    Product
    Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6 91355 89889 5, Manufactured for: Hammond's Candies, 5735 Washington St, Denver, CO 80216. Cookies are packaged in sealed, opaque, white, plastic bag, which is packed inside printed on cardstock box. There are 8 boxes…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0224-2023·2022-11-16

    Medical Device Recall: ORISE Gel Submucosal Lifting Agent Due to Foreign Body Reactions

    Boston Scientific is recalling ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions to retained gel. These reactions caused mass formations requiring surgical intervention.

    Product
    ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Recalled for Infant Safety

    Cardinal Health is recalling its insulated gel pack because it should not be used on infants or neonates. The product labeling will be updated with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2023·2022-11-16

    Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access

    MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.

    Product
    Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-0222-2023·2022-11-16

    X-Guide X-Mark Probe Tool Recall: Missing Weld Creates Aspiration Risk

    X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.

    Product
    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2023·2022-11-16

    Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update

    iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.

    Product
    Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0191-2023·2022-11-16

    Cardinal Health insulated gel pack recalled for infant contraindication

    Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2023·2022-11-16

    Cardinal Health Insulated Gel Pack recalled; not safe for infants

    Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2023·2022-11-16

    FERNO POWER X1 ambulance cot batteries pose fire and burn risk

    Ferno-Washington is recalling 1,922 FERNO POWER X1 ambulance cots with 36V Li-Ion batteries that may become unstable and pose a fire or burn injury risk if dropped, power washed, or abused.

    Product
    FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates

    Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0144-2023·2022-11-16

    Sesame sticks recalled due to undeclared cashew allergen

    JLM Manufacturing LLC is recalling JLM Sesame Sticks Mix (11oz tubs) because units may contain undeclared cashew, a common allergen. The recall affects 307 cases distributed across 18 states.

    Product
    JLM Sesame Sticks Mix in clear plastic 11oz. tub UPC 094776081646 12 retail units per case
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0185-2023·2022-11-16

    Reusable gel pack recalled due to infant use contraindication

    Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Restricted for Infants

    Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.

    Product
    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2023·2022-11-16

    Sedecal Soltus Battery Mobile X-Ray Systems Recalled for Unintended Movement

    Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.

    Product
    Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Food)·F-0145-2023·2022-11-16

    JLM Sunflower Meat recalled for undeclared cashew allergen

    JLM Sunflower Meat Roasted/Salted is recalled for undeclared cashew allergen affecting 175 cases across 18 states. Consumers with tree nut allergies should not consume.

    Product
    JLM Sunflower Meat Roasted/Salted in clear plastic 10oz. tubs UPC 760208118135 12 retail units per case
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0193-2023·2022-11-16

    Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerability

    Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.

    Product
    Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-0197-2023·2022-11-16

    Orthopedic Surgical Blade Recall Due to Incorrect Configuration

    Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.

    Product
    Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0190-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Reusable Medium Contraindicated for Infant Use

    Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V846000·2022-11-16

    2022 Utilimaster Aeromaster Recalled for Incorrect Side-View Image Display

    Shyft Group is recalling 2022 Utilimaster Aeromaster vehicles because the side-view image may display the wrong side of the vehicle when the turn signal and brake are applied simultaneously.

    Product
    UTILIMASTER — UTILIMASTER AEROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0142-2023·2022-11-16

    Gourmet Caramel Popcorn Recalled for False Gluten-Free Claim

    Rieckhoff Family Businesses is recalling Gourmet Old-Fashioned Caramel Holiday Popcorn boxes because the label falsely claims the product is gluten-free, though it contains wheat and barley.

    Product
    Gourmet Old-Fashioned Caramel Holiday Popcorn, 18oz box, UPC 25606 00061
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0192-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Recalled for Unsafe Infant Use

    Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.

    Product
    Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0220-2023·2022-11-16

    Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.

    Product
    VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2023·2022-11-16

    Dialysis concentrate labeling error for chemical composition

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.

    Product
    NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
    Category
    Medical Device
    Distribution
    21 states
  • SevereNHTSA·22V845000·2022-11-15

    Nova Bus Recalls LFS Models Due to Steering Fastener Risk

    Nova Bus is recalling 2018-2022 LFS and 2018-2021 LFS Artic buses because steering fasteners may loosen, causing loss of steering and increasing crash risk.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide