The Recall Desk

State

Montana product recalls

73,584 recalls have nationwide distribution and so reach Montana. 3,572 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,572
Critical
688
Severe
953
Most recent
2026-10-14

Of the 3,572 recalls naming Montana we have scored against our rubric, 688 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 953 (27%) are Severe.

These figures cover only the 3,572 recalls whose distribution notice names Montana specifically. The 73,584 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

27601–27625 of 77156

  • HighFDA (Devices)·Z-0627-2021·2020-12-23

    Biomet Ringloc Acetabular System Screws Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Ringloc Acetabular System self-tapping bone screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2021·2020-12-23

    Biomet Recalls Titanium IFS Devices Due to Potential Sterile Seal Breach

    Biomet, Inc. is recalling 7,428 units of Titanium IFS devices (Item 909680) because a breach in the sterile seal could lead to loss of sterility.

    Product
    Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2021·2020-12-23

    Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.

    Product
    6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2021·2020-12-23

    Biomet Phoenix Interlocking Screws Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Phoenix interlocking screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2021·2020-12-23

    Biomet RapidFire Clip Recall Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of RapidFire Clips used for craniofacial bone fixation because a breach in the sterile seal could lead to loss of sterility.

    Product
    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2021·2020-12-23

    Biomet RingLoc+ Drill Bits Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RingLoc+ Quick Connect Drill Bits because a breach in the sterile seal could lead to loss of sterility.

    Product
    RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2021·2020-12-23

    Biomet Recalls Cannulated Screw Systems Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.

    Product
    3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0624-2021·2020-12-23

    Biomet Oxford Fixed Lateral Knee Implants Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Oxford Fixed Lateral knee implants because a breach in the sterile seal could lead to loss of sterility.

    Product
    Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2021·2020-12-23

    FDA Recalls Tempus LS Manual Defibrillators Due to Software Error

    Remote Diagnostic Technologies is recalling 175 Tempus LS manual defibrillators because a software error may delay therapy by disrupting ECG calibration.

    Product
    Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2021·2020-12-23

    Enterix Recalls InSure ONE Test Strips Due to Potential False Positives

    Enterix, Inc. is recalling InSure ONE Test Strips because they may produce false positive results, potentially leading to unnecessary medical procedures.

    Product
    InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2021·2020-12-23

    RaySearch Recalls RayStation and RayPlan Software Due to Treatment Plan Errors

    RaySearch is recalling RayStation and RayPlan software versions due to potential errors in treatment plan reports, including incorrect dose information and couch angles.

    Product
    RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21057·2020-12-23

    GSK Recalls Five Excedrin Brands Due to Child-Resistant Packaging Defects

    GSK Consumer Healthcare is recalling five Excedrin brands because some bottles have holes in the bottom, posing a risk of poisoning to children.

    Product
    Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2021·2020-12-23

    Biomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.

    Product
    OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2021·2020-12-23

    Carl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling VISULENS 550 refractive power measurement devices due to a defective communication board that may cause electrical shocks.

    Product
    Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2021·2020-12-23

    Biomet Recalls Sterile Trac System Thinflap Burr Hole Plates

    Biomet is recalling specific lots of Sterile Trac System Thinflap 24 MM Burr Hole Plates because a breach in the sterile seal could lead to loss of sterility.

    Product
    Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0620-2021·2020-12-23

    Biomet Shoulder System Surgical Handles Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of sterile shoulder system surgical instrument handles because a breach in the packaging seal could lead to loss of sterility.

    Product
    Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2021·2020-12-23

    Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.

    Product
    Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach

    Maquet Cardiovascular is recalling the HLS Set Advanced because of breaches in the product's sterility barrier. The device is used with the CARDIOHELP system for cardiac and pulmonary support.

    Product
    HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches

    Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.

    Product
    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2021·2020-12-23

    Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile packaging seal could lead to loss of sterility.

    Product
    4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0628-2021·2020-12-23

    Biomet Hip Prosthesis Recall for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RINGLOC BIPOLAR Hip System components due to a potential breach in the sterile seal, which could lead to loss of sterility.

    Product
    RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2021·2020-12-23

    BD PrecisionGlide Needles Recalled Due to Blood Contamination

    Becton Dickinson is recalling BD PrecisionGlide needles because blood was found on the cannulas, posing a potential infection risk if not noticed by clinicians.

    Product
    BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V810000·2020-12-23

    International DuraStar and WorkStar Engine Control Software Defect Recall

    Navistar recalls 17,213 2014-2021 International commercial trucks with an engine control defect. The software flaw can cause unexpected vehicle movement when parked with the PTO engaged, risking crashes and injury.

    Product
    INTERNATIONAL — INTERNATIONAL MV, DURASTAR, WORKSTAR, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0636-2021·2020-12-23

    Kowa VK-2s Software Recall for Potential Patient Data Deletion

    Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.

    Product
    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V811000·2020-12-23

    GM Recalls Bolt EV and Other Vehicles for Seat Belt Attachment Defect

    General Motors is recalling multiple 2020-2021 vehicles due to incorrect bolts used to secure seat belts. Improperly fastened seat belts may fail to properly restrain occupants in a crash.

    Product
    CHEVROLET — CHEVROLET, CADILLAC, GMC SUBURBAN, ESCALADE NA, COLORADO, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide