The Recall Desk

State

Indiana product recalls

72,936 recalls have nationwide distribution and so reach Indiana. 9,555 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,555
Critical
1,903
Severe
2,136
Most recent
2026-09-09

Of the 9,555 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 9,555 recalls whose distribution notice names Indiana specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3326–3350 of 82491

  • HighFDA (Devices)·Z-1347-2026·2026-02-18

    Azurion 7 B20 systems recalled over tables that may move unexpectedly

    Philips is recalling 1 of the Azurion 7 B20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2026·2026-02-18

    Suture removal trays recalled over open swabstick applicator seals

    Medline is recalling 2,448 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0336-2026·2026-02-18

    Vancomycin injection bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling 1,578 bags of Vancomycin HCl injection over a lack of assurance of sterility.

    Product
    vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2026·2026-02-18

    GammaPlan 11.1 recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan version 11.1 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2026·2026-02-18

    Catheter securement dressing kits recalled over open swabstick seals

    Medline is recalling 1,350 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2026·2026-02-18

    Azurion 3 M12 systems recalled over tables that may move unexpectedly

    Philips is recalling 291 units of the Azurion 3 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2026·2026-02-18

    Azurion 5 M20 systems recalled over tables that may move unexpectedly

    Philips is recalling 922 units of the Azurion 5 M20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2026·2026-02-18

    Blood culture kits recalled over open swabstick applicator seals

    Medline is recalling 4,300 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0335-2026·2026-02-18

    Thiamine injection bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling 10,548 bags of thiamine HCl 500 mg in sodium chloride injection over a lack of assurance of sterility.

    Product
    thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0316-2026·2026-02-18

    Testosterone 12.5mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 3,871 pellets of Testosterone, 12.5 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2026·2026-02-18

    Spinal navigation instruments recalled over incorrect array connection geometry

    Alphatec Spine is recalling 15 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2026·2026-02-18

    Display adapters recalled after the wrong configuration file was used

    Steris is recalling 10 units of the Barco MNA with HexaVue IP Integration System because the supplier used the incorrect configuration file for a limited batch of adapter components.

    Product
    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2026·2026-02-18

    Cetrorelix injection kits recalled over missing or duplicated needles inside

    Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate for Injection kits over a defective delivery system, with needles either missing from or duplicated within the kit.

    Product
    CETRORELIX ACETATE — CETRORELIX ACETATE (CETRORELIX ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2026·2026-02-18

    Navigation osteotomes recalled over incorrect array connection geometry

    Alphatec Spine is recalling 7 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1341-2026·2026-02-18

    Compact suction units recalled over electromagnetic noise above aviation limits

    Laerdal Medical is recalling 1,202 Compact Suction Unit 4 RTCA units because those made in a limited period may emit electromagnetic noise beyond the acceptable RTCA limits.

    Product
    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1358-2026·2026-02-18

    Newborn monitor caps recalled over an incorrect sizing guide on labeling

    SurePulse Medical is recalling the Surepulse VS Cap Medium because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1337-2026·2026-02-18

    Dental impression posts recalled over caps in the wrong colour

    Straumann USA is recalling 561 WB Impression Post Closed Tray units because the impression caps provided in the package are magenta instead of brown.

    Product
    WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1359-2026·2026-02-18

    Large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1356-2026·2026-02-18

    Extra small newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Extra Small because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1360-2026·2026-02-18

    Extra large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Extra Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1357-2026·2026-02-18

    Small newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Small because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide