The Recall Desk

State

Indiana product recalls

72,969 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 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6101–6125 of 82525

  • HighFDA (Devices)·Z-2208-2025·2025-08-06

    Philips Ingenia Ambition S gradient coils may act as heat source

    Ingenia Ambition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 611 units are affected.

    Product
    Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2025·2025-08-06

    Philips Ingenia 3.0T gradient coils may act as a heat source

    Ingenia 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 1,467 units are affected.

    Product
    Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2025·2025-08-06

    LVP dual-inlet administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2025·2025-08-06

    SmartPath to dStream XR gradient coils may act as heat source

    SmartPath to dStream for XR and 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 294 units affected.

    Product
    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2025·2025-08-06

    Blood MacConkey biplates may carry Listeria monocytogenes surface contamination

    Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 units are affected.

    Product
    Blood/MacConkey Biplate 100/PK, Product Number R02049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2025·2025-08-06

    Philips Evolution Upgrade 3.0T gradient coils may act as heat source

    Evolution Upgrade 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 50 units are affected.

    Product
    Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2025·2025-08-06

    Philips Ingenia Ambition X gradient coils may act as heat source

    Ingenia Ambition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 690 units are affected.

    Product
    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2025·2025-08-06

    Philips Achieva 3.0T gradient coils may act as a heat source

    Achieva 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 460 units are affected.

    Product
    Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2025·2025-08-06

    SmartPath to Ingenia Elition X gradient coils may overheat

    SmartPath to Ingenia Elition X systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 33 units affected.

    Product
    SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2025·2025-08-06

    RAPIDPoint 500 wash waste cartridge lot biases seven blood analytes

    A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.

    Product
    RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2025·2025-08-06

    Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

    Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.

    Product
    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2025·2025-08-06

    Philips MRI Machine Intera 3.0T Quasar Dual Recalled for Fire Risk

    Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.

    Product
    Intera 3.0T Quasar Dual Model Number (REF): 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2025·2025-08-06

    CoSense sampling sets may carry residual carbon monoxide from insufficient aeration

    Precision Sampling Sets for the CoSense End-Tidal Carbon Monoxide Monitor are being recalled because residual carbon monoxide may remain in the cannula filter, which may raise ETCOc scores. 2,160 units affected.

    Product
    Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2025·2025-08-06

    Philips Ingenia Elition S gradient coils may act as a heat source

    Ingenia Elition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 242 units are affected.

    Product
    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2025·2025-08-06

    Philips Evolution Upgrade 1.5T gradient coils may act as a heat source

    Evolution Upgrade 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 93 units are affected.

    Product
    Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2025·2025-08-06

    Phasor neurosurgical drills may have a reverse battery orientation

    The Phasor Drill, used in neurosurgical procedures, is being recalled because it may have a reverse battery orientation, which may increase surgical time. 1,064 units are affected.

    Product
    Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

    Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2231-2025·2025-08-06

    3M Ranger irrigation fluid warming set notice clarifies flow rates

    The 3M Ranger Irrigation Fluid Warming Set is subject to a notice issued to clarify flow rates related to the inlet fluid temperature. 186,880 units are affected.

    Product
    3M Ranger Irrigation Fluid Warming Set, REF 24750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2025·2025-08-06

    LYFO-DISK M. canis single packs may fail to recover the organism

    LYFO-DISK M. canis preparations, REF 0894L, are being recalled because they may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2025·2025-08-06

    LYFO-DISK M. canis multipacks may fail to recover the organism

    LYFO-DISK M. canis preparations in 6-pack and 2-pack formats are being recalled because they may result in failure to recover the target microorganism. 32 units are affected.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2025·2025-08-06

    Timolol eye drop caps can lodge a spike in the nozzle

    Timolol Maleate Ophthalmic Solution USP 0.5% is being recalled because of a defective container: the spike of the cap becomes lodged in the nozzle of the bottle. 154,176 bottles affected.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2193-2025·2025-08-06

    Sprinter Cart infusion poles do not meet IEC 60601-1 labeling requirements

    Sprinter Cart and Sprinter Cart XL Infusion Poles are being recalled because the device does not comply with the labeling requirements of international standard IEC 60601-1. 7,754 units affected.

    Product
    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2025·2025-08-06

    Sterilizable Drill Stop Kits were shipped containing incorrect components

    The Drill Stop Kit, a version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length, is being recalled because it contains incorrect components. 45 kits affected.

    Product
    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops
    Category
    Medical Device
    Distribution
    Distributed nationwide