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.

5826–5850 of 76537

  • HighFDA (Devices)·Z-2211-2025·2025-08-06

    Philips Ingenia Elition X gradient coils may act as heat source

    Ingenia Elition 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. 632 units are affected.

    Product
    Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
    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-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-2205-2025·2025-08-06

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

    Ingenia 1.5T 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. 136 units are affected.

    Product
    Ingenia 1.5T S Model Number (REF): 781347;
    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-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-2221-2025·2025-08-06

    Volcano Visions IVUS catheters can entangle with the guide wire

    Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.

    Product
    Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
    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-2225-2025·2025-08-06

    Blood EMB Levine plates may carry Listeria monocytogenes contamination

    Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.

    Product
    Blood/EMB, Levine 100/PK, Product Number R02041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2025·2025-08-06

    HeartSine samaritan public access defibrillators may not deliver shocks properly

    HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.

    Product
    HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
    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 (Drugs)·D-0545-2025·2025-08-06

    Bicillin L-A 2.4 million unit vials recalled after particulates found

    Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    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-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
  • 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-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 (Drugs)·D-0544-2025·2025-08-06

    Bicillin L-A penicillin vials recalled after particulates found during visual inspection

    Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2025·2025-08-06

    Philips MR 5300 gradient coils may act as a heat source

    MR 5300 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. 551 units are affected.

    Product
    MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2025·2025-08-06

    Osteotec silicone finger implants may contain foreign material

    Osteotec Silicone Finger Implants in sizes 3, 4 and 5 are being recalled because there is the potential that the silicone implant may contain foreign material. 15,573 units are affected.

    Product
    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2025·2025-08-06

    Philips MR 7700 upgrade gradient coils may act as a heat source

    Upgrade to MR 7700 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. 26 units are affected.

    Product
    Upgrade to MR 7700 Model Number (REF): 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2025·2025-08-06

    HarmonyAIR dual flat panel monitor yokes may detach from spring arm

    Dual Flat Panel Monitor accessories for HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 167 units are affected.

    Product
    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2025·2025-08-06

    SmartPath to dStream 3.0T gradient coils may act as heat source

    SmartPath to dStream for 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. 15 units affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145;
    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