The Recall Desk

State

Montana product recalls

72,940 recalls have nationwide distribution and so reach Montana. 3,567 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,567
Critical
689
Severe
783
Most recent
2026-09-02

Of the 3,567 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 3,567 recalls whose distribution notice names Montana specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3551–3575 of 76507

  • ModerateFDA (Devices)·Z-1142-2026·2026-01-28

    M3 vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 13,934 units of its M3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-inv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1154-2026·2026-01-28

    iM8 series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 3,141 units of its Patient Monitor models iM8, iM8A and iM8B after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and cont
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0291-2026·2026-01-28

    Diclofenac topical gel recalled after failing pH specifications

    Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel 1% after the batch failed pH specifications.

    Product
    DICLOFENAC SODIUM — DICLOFENAC SODIUM (DICLOFENAC SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1143-2026·2026-01-28

    iM3 vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 11,987 units of its iM3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2026·2026-01-28

    Gait training devices recalled over potential fraying on the body support strap

    Community Products is recalling 470 units of the Rifton E-Pacer gait training device over potential fraying on the body support strap.

    Product
    Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1137-2026·2026-01-28

    TRAM powered lift devices recalled over potential strap fraying

    Community Products is recalling 3,238 units of the Rifton TRAM over potential fraying on the body support strap.

    Product
    Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2026·2026-01-28

    M3A vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 12,201 units of its M3A Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2026·2026-01-28

    Distal radius plates recalled over an incorrect thread orientation

    Tyber Medical is recalling 100 VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2026·2026-01-28

    Laboratory tube sorters recalled over a lift that may drop unexpectedly

    Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.

    Product
    TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2026·2026-01-28

    Long distal radius plates recalled over an incorrect thread orientation

    Tyber Medical is recalling 64 units VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2026·2026-01-28

    M3B vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 354 units of its M3B Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2026·2026-01-28

    MFM-CNS clinical data software recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 395 units of its Central Monitoring System models MFM-CNS and MFM-CNS Lite after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2026·2026-01-28

    Fetal monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 3,721 units of its Fetal Monitor models F2 and F3 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1134-2026·2026-01-28

    iM series patient monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 14,550 units of its Patient Monitor models iM50, iM60, iM70 and iM80 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System
    Category
    Medical Device
    Distribution
    51 states
  • LowFDA (Devices)·Z-1130-2026·2026-01-28

    Surgical laser consoles recalled over a label missing the DANGER symbol

    Leaseir Technologies is recalling two MHR Xcell surgical laser systems because the console label on the affected devices is missing the "DANGER" symbol.

    Product
    Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V044000·2026-01-26

    Grand Design fifth wheel U-bolts may loosen and shift the axle

    Grand Design is recalling certain 2021-2024 Momentum and 2022-2024 Solitude fifth wheel trailers because the U-bolt may become loose, causing the axle to move out of position.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM, SOLITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V046000·2026-01-26

    Kia vehicles recalled for instrument panel display software failure

    Kia is recalling multiple 2025–2026 models due to a software error that may cause the instrument panel display to fail, potentially hiding critical safety information like the speedometer and warning lights.

    Product
    KIA — KIA SPORTAGE PHEV, SORENTO PHEV, SPORTAGE HYBRID, SPORTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V047000·2026-01-26

    Hyundai vehicles instrument panel display software error recall

    Hyundai is recalling certain 2025–2026 Tucson Hybrid, Tucson PHEV, and other 2026 models due to a software error that may cause the instrument panel display to fail, potentially hiding critical safety information like the speedometer and warning lights.

    Product
    HYUNDAI — HYUNDAI IONIQ 5, KONA, PALISADE, PALISADE HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V045000·2026-01-26

    Keystone Recalls 2026 Coleman Travel Trailers Due to Bed Bracket Defect

    Keystone is recalling 2026 Coleman travel trailers because bed brackets may not be secured to a stud, causing the bed to fall unexpectedly and increasing injury risk.

    Product
    KEYSTONE — KEYSTONE COLEMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V035000·2026-01-23

    FWMoto Recalls FLY-10 E-Bikes Due to Insufficient Brake Performance

    FWMoto is recalling 2022-2024 FLY-10 e-bikes because brake pads may provide insufficient braking performance, increasing the risk of a crash.

    Product
    FLY E-BIKE — FLY E-BIKE, FWMOTO FLY-10
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V040000·2026-01-23

    Forest River Bus Recalls 2026 Collins Buses for Body Panel Adhesive Defect

    Forest River Bus is recalling 2026 Collins Bus transit buses because body panel adhesive may be applied incorrectly, causing panels to separate and reducing structural integrity.

    Product
    FOREST RIVER BUS — FOREST RIVER BUS COLLINS BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V042000·2026-01-23

    Grand Design Lineage solar panel adhesive may fail allowing detachment

    Grand Design is recalling certain 2025-2026 Lineage recreational vehicles because the adhesive securing the solar panels to the roof may fail, allowing a panel to detach.

    Product
    GRAND DESIGN — GRAND DESIGN LINEAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V037000·2026-01-23

    Polestar 3 rear seat backrest striker brackets may be loose

    Polestar is recalling certain 2025 Polestar 3 vehicles because the striker brackets that secure the rear seat backrest may be loose. This fails FMVSS 207.

    Product
    POLESTAR — POLESTAR POLESTAR 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V043000·2026-01-23

    2026 Brinkley RV Model Z Trailers Recalled for Fire Risk

    Brinkley RV is recalling certain 2026 Model Z trailers because shore power inlet lugs may be improperly tightened, causing wires to loosen, overheat, and create a fire hazard.

    Product
    BRINKLEY RV — BRINKLEY RV MODEL Z
    Category
    Vehicle
    Distribution
    Distributed nationwide