The Recall Desk

State

Indiana product recalls

73,833 recalls have nationwide distribution and so reach Indiana. 9,598 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,598
Critical
1,908
Severe
2,536
Most recent
2026-11-04

Of the 9,598 recalls naming Indiana we have scored against our rubric, 1,908 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,536 (26%) are Severe.

Which agencies issued them

These figures cover only the 9,598 recalls whose distribution notice names Indiana specifically. The 73,833 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

54376–54400 of 83431

  • SevereFDA (Devices)·Z-1894-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing loss of power to the User Interface Module.

    Product
    TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1899-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA GDE upgrade kits because an incorrect fuse may fail, causing loss of power to the ventilator's user interface.

    Product
    AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2016·2016-06-22

    Fresenius Kabi Recalls Sensorcaine Due to Glass Particulate Matter

    Fresenius Kabi is recalling specific lots of Sensorcaine injection because glass particulate matter was found in the sterile product.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1889-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing a loss of power to the user interface module.

    Product
    AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA Ventilator upgrade kits because an incorrect fuse may fail, causing loss of power to the User Interface Module.

    Product
    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1897-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling 922 AVEA Ventilators worldwide because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V456000·2016-06-22

    Mack Recalls 2013 Pinnacle Trucks Due to Front Axle Fracture Risk

    Mack Trucks is recalling 2013 Pinnacle (CXU) trucks because improperly heat-treated front axles may fracture, increasing the risk of a crash.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1890-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V455000·2016-06-22

    Winnebago Recalls 2014-2016 Motorhomes Due to Throttle Sensor Defect

    Winnebago is recalling 2014-2016 Tour and Itasca Ellipse motorhomes because a throttle sensor defect may prevent the engine brake from activating, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA TOUR, ELIPSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1896-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2016·2016-06-22

    Hospira Recalls Vancomycin Hydrochloride Injection Due to Cardboard Particulate Matter

    Hospira Inc. is recalling specific lots of Vancomycin Hydrochloride for Injection due to the presence of cardboard particulate matter.

    Product
    Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1893-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1895-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2016·2016-06-22

    Zimmer Dome Centric Shoulder Implant Component Recalled for Assembly Issues

    Zimmer GmbH is recalling 177 Dome Centric components from the Anatomical Shoulder System 2.0 because they may be difficult to disassemble during surgery, potentially causing delays or incomplete procedures.

    Product
    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1947-2016·2016-06-22

    Cordis PRECISE RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE RX Nitinol Stent Systems (Biliary) due to the inability to deploy the stent or partial deployment.

    Product
    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2016·2016-06-22

    Navilyst Medical Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 1,127 Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

    Product
    BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1945-2016·2016-06-22

    Sysmex XN-Series Hematology Analyzers Recalled for Potential Elevated Values

    Sysmex Corporation is recalling XN-10 and XN-20 hematology analyzers due to a potential for elevated hemoglobin and impedance platelet count values.

    Product
    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1979-2016·2016-06-22

    Navilyst Medical Recalls Xcela Hybrid PICC Catheters with Valve Technology

    Navilyst Medical is recalling 157 units of Xcela Hybrid PICC catheters because they lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 105 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2016·2016-06-22

    Stryker PowerPRO Cots Recalled for Smoke and High-Speed Retract Reports

    Stryker is recalling 770 PowerPRO ambulance cots due to reports of smoke from the foot end and unexpected high-speed retraction.

    Product
    Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 568 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide