The Recall Desk

State

Montana product recalls

73,388 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
952
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 952 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,388 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

21976–22000 of 76959

  • HighFDA (Drugs)·D-0755-2022·2022-04-13

    Pfizer Accuretic Blood Pressure Tablets Recalled for Chemical Impurity

    Pfizer is recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets nationwide due to unacceptable levels of N-nitroso chemical impurities from manufacturing deviations. The affected lot includes 160 bottles.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2022·2022-04-13

    Abbott ARCHITECT STAT myoglobin calibrators recalled for calibration failure

    Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.

    Product
    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0741-2022·2022-04-13

    Tetracaine Injection Recalled for Sterility Assurance Manufacturing Defect

    Tetracaine 1% Injectable is being recalled due to sterility assurance failures caused by manufacturing deviations that may compromise product sterility.

    Product
    TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2022·2022-04-13

    Medline Excelsior Medical Sterile Saline Flush Syringes Recalled for Sterility Failure

    Medline Industries is recalling 7,800 Excelsior Medical 10mL Sterile Field Saline Flush syringes due to sterility failure of the exterior syringe surface, which may prevent the product from being safely used on a sterile field.

    Product
    Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2022·2022-04-13

    Total Knee Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.

    Product
    Total Knee Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V245000·2022-04-13

    2021-2022 Volkswagen Atlas Fuel Injector Fire Risk Recall

    Volkswagen is recalling 2021-2022 Atlas and Atlas Cross Sport vehicles because some fuel injectors lack filters, potentially causing fuel leaks and increasing fire risk. Dealers will replace affected injectors at no cost.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2022·2022-04-13

    Defibrillator devices unapproved for US market recalled by FDA

    Remote Diagnostic Technologies recalls Tempus LS defibrillators not approved for US distribution. Two units were distributed in Illinois and Kansas.

    Product
    Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0742-2022·2022-04-13

    Drug recall: Papaverine hydrochloride injection due to sterility concerns

    Vitae Enim Vitae Scientific, Inc. is recalling papaverine hydrochloride injection nationwide due to manufacturing deviations that compromise sterility assurance in this intravenous drug product.

    Product
    PAPAVERINE HYDROCHLORIDE — PAPAVERINE HYDROCHLORIDE (PAPAVERINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2022·2022-04-13

    X-ray System Models Recalled for Potential Radiation Dose Exceeding Standards

    Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.

    Product
    MODEL: X-RAY TV SYSTEM SONIALVISION G4
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0874-2022·2022-04-13

    Philips Allura and Azurion X-ray systems may display incorrect previous images

    Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.

    Product
    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2022·2022-04-13

    GE SIGNA Excite 3T MRI Systems Recalled Over Potential Image Flip

    GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.

    Product
    SIGNA Excite 3T. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2022·2022-04-13

    Philips StentBoost Live imaging system acquisition malfunction recall

    Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.

    Product
    Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0747-2022·2022-04-13

    NETSPOT prescription drug kit recalled for subpotency in vial 1

    Advanced Accelerator Applications recalls approximately 14,089 NETSPOT kits distributed nationwide due to subpotency detected during stability studies. The affected lots contain insufficient active ingredient concentration.

    Product
    NETSPOT — NETSPOT (68GA-DOTATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0749-2022·2022-04-13

    Sucralfate Oral Suspension Recalled Due to Label Mix-Up

    DASH Pharmaceuticals is recalling Sucralfate Oral Suspension nationwide due to a labeling mix-up affecting approximately 45,940 unit dose cups.

    Product
    Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0762-2022·2022-04-13

    Risedronate Sodium Tablets Recalled for Failed Content Uniformity Specifications

    Macleods Pharma USA Inc is recalling Risedronate Sodium 5 mg tablets (Lot BRD2001A, expiration 5/2022) due to failed content uniformity specifications. The recall affects 4,872 bottles distributed nationwide.

    Product
    RISEDRONATE SODIUM — RISEDRONATE SODIUM (RISEDRONATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0770-2022·2022-04-13

    Ophthalmic drug recalled for subpotency and particulate matter

    Sun Pharmaceutical recalls CEQUA cyclosporine ophthalmic solution nationwide due to low assay results and particulate matter found in specific lots.

    Product
    CEQUA — CEQUA (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0888-2022·2022-04-13

    Brius Pontics Orthodontic Devices Recalled for Incomplete Design Validation

    Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and documentation.

    Product
    Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2022·2022-04-13

    Vena Cava Filter Sets Recalled for Instruction for Use Documentation Updates

    Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.

    Product
    Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0752-2022·2022-04-13

    FDA Voluntary Recall of Methylprednisolone Tablets for Subpotency

    Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets USP 4mg because they contain less active ingredient than labeled. Lot 21 P0322 was distributed nationwide and in Puerto Rico.

    Product
    Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0856-2022·2022-04-13

    Oral gel recalled for failed microbial testing

    SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel due to failed microbial testing. Consumers should not use the product and contact their healthcare provider or SA3, LLC.

    Product
    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0889-2022·2022-04-13

    Brius Patient Specific Brackets recalled without completing design control process

    Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.

    Product
    Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0758-2022·2022-04-13

    Quinapril and Hydrochlorothiazide Tablets Recalled for Elevated Chemical Impurity

    Pfizer is recalling quinapril and hydrochlorothiazide tablets (20 mg/25 mg) nationwide due to elevated chemical impurities exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0730-2022·2022-04-13

    X-ray system displays incorrect collimation area information

    The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.

    Product
    YSIO X.Pree
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0751-2022·2022-04-13

    Oral antiseptic rinse recalled due to label mix-up and wrong barcode

    The Natural Dentist Healthy Breath Antiseptic Rinse (Cool Mint) is being recalled due to a label mix-up. The back label incorrectly states the active ingredient as Peppermint Oil and Sage Oil and displays the wrong UPC code.

    Product
    The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714.
    Category
    Drug
    Distribution
    Distributed nationwide