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.

3526–3550 of 76507

  • HighFDA (Devices)·Z-1121-2026·2026-01-28

    SIGMA Spectrum infusion pumps recalled over defective grease on the gears

    Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.

    Product
    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2026·2026-01-28

    PET scanners recalled over a streaking artifact in clinical images

    GE HealthCare is recalling 364 Omni Legend PET systems because an intermittent issue can produce a streaking artifact in PET clinical scan images.

    Product
    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2026·2026-01-28

    Needle free access connectors recalled over silicone seals that may tear

    ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.

    Product
    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V049000·2026-01-28

    Toyota Prius models recalled for unexpected rear door opening risk

    Toyota is recalling certain 2023–2026 Prius and Prius Prime models because water may enter the rear door switch, causing an unlocked door to open unexpectedly while driving. This increases injury risk.

    Product
    TOYOTA — TOYOTA PRIUS PLUG-IN HYBRID, PRIUS PRIME, PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2026·2026-01-28

    Angioplasty packs recalled over inflation handles that may detach

    Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Angioplasty Pack REF: IS-30-B1/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0295-2026·2026-01-28

    Icosapent ethyl capsules recalled as subpotent after capsule contents leaked

    Zydus Pharmaceuticals is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, because oxidation caused by leakage of the capsule contents has left them subpotent.

    Product
    Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0294-2026·2026-01-28

    Bulk thyroid drug substance recalled as subpotent from one lot

    Specialty Process Labs is recalling one lot of Thyroid, USP bulk drug substance because it is subpotent.

    Product
    Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2026·2026-01-28

    Custom procedure kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2026·2026-01-28

    basixCOMPAK inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2026·2026-01-28

    Angiographic inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Inflation Device, for angiographic use REF: IS-30-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2026·2026-01-28

    Waste management vascular trays recalled over inflation handles that may detach

    Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2026·2026-01-28

    Plum Solo pumps recalled over hard limit messages blocking flush programming

    ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
    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 (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-1144-2026·2026-01-28

    iM3s series vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 136 units of its Vital Signs Monitor models iM3s, iM3As, iM3Bs and iHM3s 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: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts fo
    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-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-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-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 (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-1138-2026·2026-01-28

    iM20 patient monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. 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. The low base variant includes smaller casters and lower base frame so that th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2026·2026-01-28

    Elite V series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 342 units of its Patient Monitor models elite V5, elite V6 and elite V8 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Als
    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