The Recall Desk

State

Montana product recalls

72,969 recalls have nationwide distribution and so reach Montana. 3,568 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,568
Critical
689
Severe
783
Most recent
2026-09-16

Of the 3,568 recalls naming Montana we have scored against our rubric, 689 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 783 (22%) are Severe.

These figures cover only the 3,568 recalls whose distribution notice names Montana specifically. The 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5851–5875 of 76537

  • 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-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-2233-2025·2025-08-06

    LVP blood administration sets have potential for external cassette leaks

    LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.

    Product
    LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2025·2025-08-06

    Strep Selective II Agar plates may carry Listeria monocytogenes contamination

    Strep Selective II Agar, product number R01859, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 371 units are affected.

    Product
    Strep Selective II Agar, Product Number R01859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2025·2025-08-06

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

    Ingenia 3.0T CX 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. 350 units are affected.

    Product
    Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
    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-2235-2025·2025-08-06

    LVP dual Y-site administration sets have potential for external cassette leaks

    LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2025·2025-08-06

    Blood agar plates may carry Listeria monocytogenes surface contamination

    Blood Agar with 5% Sheep Blood, product number R01202, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 1,552 units affected.

    Product
    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2025·2025-08-06

    HarmonyAIR E-Series monitor yokes may detach from the spring arm

    Dual Flat Panel Monitor accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 59 units are affected.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
    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-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-2204-2025·2025-08-06

    Philips Ingenia 1.5T gradient coils may act as a heat source

    Ingenia 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. 2,279 units are affected.

    Product
    Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2025·2025-08-06

    Philips Achieva XR gradient coils may act as a heat source

    Achieva XR 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. 40 units are affected.

    Product
    Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2025·2025-08-06

    IontoPatch 80 nonwoven pads do not absorb the saline solution

    IontoPatch 80 On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 63,936 units affected.

    Product
    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0380-2025·2025-08-06

    Organic Pure Stevia bottles actually contain mislabeled monk fruit powder

    Organic Pure Stevia, 1 oz, is being recalled because the product is monk fruit powder but the bottle was mislabeled as Organic Pure Stevia. 78 bottles are affected.

    Product
    Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Product is packaged in a plastic bottle with white cap. Ingredient: Organic Stevia Extract. Sprinkle a pinch for the perfect sweetness. Suggested Use: 1/64 tsp tastes as sweet as 1 tsp of sugar. Distributed by: NuNaturals, I
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2196-2025·2025-08-06

    IontoPatch STAT nonwoven pads do not absorb the saline solution

    IontoPatch STAT On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 80,928 units affected.

    Product
    IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
    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
  • 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 (Food)·H-0381-2025·2025-08-06

    Pure Monk Fruit Sweetener bottles actually contain mislabeled stevia powder

    Pure Monk Fruit Sweetener, 0.71 oz, is being recalled because the product is stevia powder but the bottle was mislabeled as Pure Monk Fruit Sweetener. 78 bottles are affected.

    Product
    Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so much sweeter than sugar, a pinch is all you need. Suggested Use: Add to sweeten your food or be
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2025·2025-08-06

    BostonSight scleral lenses made with sagittal height or haptic errors

    BostonSight SCLERAL Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 441 units are affected.

    Product
    BostonSight SCLERAL Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2025·2025-08-06

    BostonSight PROSE lenses made with sagittal height or haptic errors

    BostonSight PROSE Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 38 units are affected.

    Product
    BostonSight PROSE Lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2025·2025-08-06

    Amlodipine and benazepril capsules released with the wrong expiry date

    Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg are being recalled because they were released with the wrong expiry date, printed as February 2027 instead of January 2027. 7,668 bottles affected.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    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