The Recall Desk

State

Montana product recalls

73,570 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
689
Severe
952
Most recent
2026-10-14

Of the 3,572 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 952 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,572 recalls whose distribution notice names Montana specifically. The 73,570 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

26251–26275 of 77142

  • HighFDA (Devices)·Z-1461-2021·2021-04-28

    Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,547 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2021·2021-04-28

    Smiths Medical Recalls Left Heart Kits Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    Left Heart Kit, Model Number M20268. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2021·2021-04-28

    Biotronik ILIVIA 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 914 ILIVIA 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V302000·2021-04-28

    2021 Hyundai Elantra seat back recliner frame welding defect

    Hyundai is recalling certain 2021 Elantra vehicles because the driver and front passenger seat back recliners may have been improperly welded and could separate during a crash, increasing injury risk.

    Product
    HYUNDAI — HYUNDAI ELANTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21118·2021-04-28

    UST Recalls LifeSeasons Iron Supplement Due to Child-Resistant Packaging Failure

    UST Mfg. LLC. is recalling LifeSeasons Blood Nourish-R iron supplements because the bottles do not meet child-resistant packaging requirements, posing a poisoning risk to young children.

    Product
    LifeSeasons Blood Nourish-R Iron Supplement
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 386 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2021·2021-04-28

    Biotronik ILIVIA NEO 7 DR-T DF-1 ProMRI Defibrillators Recalled for Battery Depletion

    Biotronik is recalling 98 ILIVIA NEO 7 DR-T DF-1 ProMRI defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21117·2021-04-28

    Sauder Woodworking Recalls Counter-Height Bar Stools Due to Fall Hazard

    Sauder Woodworking is recalling about 3,100 counter-height bar stools because the legs can become unstable, posing a fall hazard. No injuries have been reported.

    Product
    Sauder and Aliesha-May Counter-height bar stools (two-piece sets)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2021·2021-04-28

    Siemens Sensis Systems Recalled for Windows Service Permission Vulnerability

    Siemens Medical Solutions is recalling Sensis and Sensis Vibe Hemo systems due to Windows Service Permission configuration risks that could expose sensitive information or allow data manipulation.

    Product
    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2021·2021-04-28

    Siemens BCS XP System Recalled for Potential Emicizumab Carryover

    Siemens Healthcare Diagnostics is recalling BCS XP Systems due to a potential risk of Emicizumab carryover on patient samples.

    Product
    BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2021·2021-04-28

    Biotronik Intica Neo 7 HF-T Defibrillators Recalled for Battery Depletion

    Biotronik is recalling eight Intica Neo 7 HF-T implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2021·2021-04-28

    AngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns

    AngioDynamics is recalling specific lots of Smart Port CT-Implantable Port kits due to potential compromised sterility. The recall affects 267 kits distributed nationwide.

    Product
    Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1482-2021·2021-04-28

    Welch Allyn ELI 280 Electrocardiograph Recalled for Safety Standard Non-Compliance

    Welch Allyn is recalling 99 ELI 280 Electrocardiographs because they do not meet IEC 60601-2-27 safety requirements as labeled.

    Product
    ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1485-2021·2021-04-28

    Welch Allyn AM12M Acquisition Module Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 746 AM12M Acquisition Modules because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1436-2021·2021-04-28

    Stryker DirectInject Bone Cement Recalled Due to Injection Failure

    Stryker is recalling 321 units of DirectInject bone cement because the paste cannot be injected from the syringe into the target location.

    Product
    DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Recall

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update guidance on intermittent alarm issues.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0336-2021·2021-04-28

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects

    Noven Pharmaceuticals is recalling Minivelle estradiol transdermal patches because the adhesive may not stick well to the skin.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1440-2021·2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Packaging Labeling Error

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes were mislabeled, containing the wrong size device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1431-2021·2021-04-28

    Bard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects

    C.R. Bard is recalling 9,800 units of Bard Clean-Cath Intermittent Catheters because the catheter tip was cut off and the packaging was not fully sealed.

    Product
    Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1432-2021·2021-04-28

    Azure Biotech Recalls Assure COVID-19 Rapid Test Devices for Labeling Errors

    Azure Biotech Inc. is recalling 100,000 Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect diagnostic labeling and unsupported expiration dating.

    Product
    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1439-2021·2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Incorrect Size Labeling

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes misidentify the size of the contained device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1484-2021·2021-04-28

    Welch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance

    Welch Allyn is recalling 213 Surveyor S12/S19 Bedside Patient Monitors because they do not meet IEC 60601-2-27 safety requirements as labeled.

    Product
    Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2021·2021-04-28

    Welch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 27 ELI 380 Electrocardiographs because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2021·2021-04-28

    Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns

    Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed nationwide.

    Product
    Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
    Category
    Drug
    Distribution
    Distributed nationwide