The Recall Desk

State

Montana product recalls

20,364 recalls have nationwide distribution and so reach Montana. 0 additional recalls listed Montana specifically in their distribution scope.

About recalls in Montana

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Montana consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

13926–13950 of 20364

  • HighFDA (Devices)·Z-1209-2023·2023-03-15

    COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results

    DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.

    Product
    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2023·2023-03-15

    CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers

    FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2023·2023-03-15

    CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices

    St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.

    Product
    CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physician
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2023·2023-03-15

    Blood Sample Collection Kits Shipped With Incorrect Identification Labels

    LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.

    Product
    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2023·2023-03-15

    Siemens epoc Host 2 blood gas analyzer recalled for pO2 measurement quality control issue

    Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.

    Product
    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0439-2023·2023-03-15

    NaturalCare bioAllers Homeopathic Drops Recalled for Manufacturing Quality Defect

    Nutraceutical Corporation is recalling NaturalCare bioAllers homeopathic liquid drops nationwide due to a raw material manufacturing quality issue. The recall affects lot 222076 with an expiration date of 03/27.

    Product
    NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0444-2023·2023-03-15

    FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

    Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

    Product
    Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2023·2023-03-15

    Daily Harvest French Lentil Crumbles Recalled for Gastrointestinal Illness

    Daily Harvest French Lentil + leek Crumbles (Item L02-VEGBN) are being recalled due to complaints of gastrointestinal illness. The recall affects 28,776 units distributed nationwide with lot codes from September through November 2022.

    Product
    Daily Harvest French Lentil + leek Crumbles, Item ID L02-VEGBN, Net Wt. 12 oz. (340g) Keep Frozen, Cook Thoroughly. Perishable. Store Frozen. Cook Thoroughly to internal temperature of 165F. Distr. by Daily Harvest Inc. New York, NY 10013.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0434-2023·2023-03-15

    Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency

    B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2023·2023-03-15

    Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk

    Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.

    Product
    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2023·2023-03-15

    Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure

    Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.

    Product
    CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1215-2023·2023-03-15

    epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy

    Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.

    Product
    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0449-2023·2023-03-15

    Drug manufacturer recalls Soltice Quick-RUB nationwide due to manufacturing deviations

    Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.

    Product
    Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0435-2023·2023-03-15

    Heparin Sodium Injection Recalled Due to Labeling Issue

    Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0450-2023·2023-03-15

    FDA Recalls Nose Better Gel Due to Manufacturing Process Deviations

    Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.

    Product
    Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2023·2023-03-15

    Sodium fluoride oral rinse recalled for manufacturing deviations

    Activator Concentrate, a sodium fluoride oral rinse manufactured by Ecometics, Inc., was voluntarily recalled due to manufacturing practice deviations. The recall affected 34,320 bottles distributed nationwide.

    Product
    Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0442-2023·2023-03-15

    Phenylephrine HCl syringe recalled for manufacturing practice deviations

    Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.

    Product
    Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2023·2023-03-15

    BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard

    The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.

    Product
    BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0448-2023·2023-03-15

    FDA Recalls Unguentine Original Ointment for Manufacturing Practice Deviations

    Ecometics, Inc. has voluntarily recalled Unguentine Original Ointment for Burns due to manufacturing practice deviations. The recall affects 20,746 units distributed nationwide.

    Product
    Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2023·2023-03-15

    FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations

    Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.

    Product
    Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2023·2023-03-15

    Unguentine Original Pain Relief Ointment Recalled for Manufacturing Process Deviations

    Unguentine Original Pain Relief Ointment is being recalled due to manufacturing process deviations. The FDA-led voluntary recall affects nationwide distribution.

    Product
    Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0446-2023·2023-03-15

    Drug Recall: Alcolado Relampago Topical for Manufacturing Practice Deviations

    Ecometics recalls Alcolado Relampago topical product nationwide due to Current Good Manufacturing Practice deviations. About 18,000 bottles in 7 oz and 16 oz sizes were distributed in the U.S.

    Product
    Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0457-2023·2023-03-15

    Drug Recall: Purely Soothing MSM Nasal Spray due to manufacturing deviations

    Pharmedica USA is recalling Purely Soothing MSM Nasal Spray (15%, Lot #1808051) due to manufacturing practice violations. The recall affects 995 bottles distributed nationwide and internationally.

    Product
    Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0454-2023·2023-03-15

    OTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date

    Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.

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