The Recall Desk

State

Montana product recalls

73,187 recalls have nationwide distribution and so reach Montana. 3,571 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,571
Critical
689
Severe
785
Most recent
2026-09-23

Of the 3,571 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 785 (22%) are Severe.

These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,187 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

13201–13225 of 76758

  • SevereFDA (Drugs)·D-0317-2024·2024-01-31

    Robitussin Honey CF Max Nighttime Adult Recalled for Microbial Contamination

    Haleon US Holdings LLC is recalling Robitussin Honey CF Max Nighttime Adult cough medicine due to microbial contamination. The FDA Class I recall affects 21,900 bottles distributed nationwide.

    Product
    Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2024·2024-01-31

    Robitussin Honey CF Max Non-Drowsy Adult recalled for microbial contamination

    GSK Consumer Healthcare recalls Robitussin Honey CF Max Non-Drowsy Adult due to microbial contamination in non-sterile products distributed nationwide. Affected lot numbers carry specific expiration dates.

    Product
    Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V058000·2024-01-31

    Heavy truck stability control software has incorrect axle spacing parameters

    Daimler Trucks is recalling certain 2024-2025 Western Star 49X and 2025 Freightliner Cascadia vehicles whose Electronic Stability Control software carries incorrect axle spacing parameters, failing FMVSS 136.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 49X, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2024·2024-01-31

    TactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System

    The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.

    Product
    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2024·2024-01-31

    VITROS Anti-HBs Immunodiagnostic Products Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.

    Product
    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2024·2024-01-31

    Hologic PANTHER FUSION System Recalled for Potential False Positive Flu B Results

    Hologic is recalling PANTHER FUSION nucleic acid testing systems due to the potential for false positive influenza B test results when a sample is also positive for SARS-CoV-2.

    Product
    PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V055000·2024-01-31

    Motorhome retractable awnings can extend unintentionally during transit

    Jayco is recalling certain 2023 Entegra Expanse, Expanse LI, Jayco Solstice and Solstice LI motorhomes because the retractable awning may extend unintentionally while the vehicle is moving.

    Product
    JAYCO — JAYCO, ENTEGRA SOLSTICE, EXPANSE, EXPANSE LI, SOLSTICE LI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2024·2024-01-31

    Power Knee Prosthetic Batteries Recalled Due to Unexpected Shutdown Risk

    Ossur Power Knee prosthetic knee batteries may fail to turn on or shut down unexpectedly, potentially causing users to lose support and fall. Affected units are distributed nationwide.

    Product
    Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2024·2024-01-31

    EliA GBM Diagnostic Wells Recalled for False Positive Results

    Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.

    Product
    EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0272-2024·2024-01-31

    Zolpidem Tartrate Extended-Release Tablets Recalled for Manufacturing Contamination

    SUN PHARMACEUTICAL INDUSTRIES is recalling 14,568 bottles of Zolpidem Tartrate Extended-Release 12.5mg tablets nationwide due to microbial contamination discovered in manufacturing equipment. Affected lot: DNE0893A (expires 07/31/2026).

    Product
    ZOLPIDEM TARTRATE — ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0273-2024·2024-01-31

    Fexofenadine Hydrochloride Antihistamine Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.

    Product
    FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2024·2024-01-31

    Ultrasound system recalled due to measurement error in Dual Live Compare feature

    B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.

    Product
    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2024·2024-01-31

    FDA Recalls DiaSorin HSV-2 Antibody Test Lots Due to False Positive Results

    DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.

    Product
    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2024·2024-01-31

    Snapshot NIR Tissue Oxygenation System Touchscreens May Be Unresponsive

    Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.

    Product
    Snapshot NIR, REF: KD204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2024·2024-01-31

    FDA Recalls Fosaprepitant Injection Due to Sterility Assurance Failure

    BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.

    Product
    FOSAPREPITANT — FOSAPREPITANT (FOSAPREPITANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2024·2024-01-31

    Medtronic Cobalt XT DR MRI cardioverter defibrillator battery testing defect

    Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.

    Product
    Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0263-2024·2024-01-31

    Prescription Drug Cinacalcet Tablets Recalled for Manufacturing Contamination

    Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0270-2024·2024-01-31

    Prescription Niacin Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.

    Product
    NIACIN — NIACIN (NIACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2024·2024-01-31

    MRI system warning label defect presents electrical shock risk to service personnel

    Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for service personnel.

    Product
    Achieva 1.5T, Model No. 781178, 781196, 781296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2024·2024-01-31

    Benzonatate Capsules Nationwide Recall for Above-Specification Assay Results

    Amerisource Health Services is recalling 6,344 cartons of Benzonatate 100 mg capsules nationwide due to assay results that were slightly above specification. No illnesses or injuries have been reported.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide