The Recall Desk

State

Montana product recalls

73,366 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.

These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,366 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

19026–19050 of 76937

  • HighCPSC·23048·2022-11-17

    Infant Yellow Footed Fleece Pajamas Recalled for Puncture and Laceration Hazards

    The William Carter Company is recalling about 50,800 infant yellow footed fleece pajamas because small metal wire pieces found in the garment pose puncture and laceration hazards to young children. No injuries have been reported.

    Product
    Infant's Yellow Footed Fleece Pajamas with Animal Graphic
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0058-2023·2022-11-16

    Octreotide Acetate Injection Recalled for Glass Particle Contamination

    Viatris Inc is recalling Octreotide Acetate Injection due to glass particles found in syringes. Approximately 22,400 syringes of lot #AJ21002 (expiration 03/2024) were distributed nationwide.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0226-2023·2022-11-16

    Medical Device Procedure Kits Recalled for Foreign Body Reaction Risk

    Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher incidence of foreign body reactions to remnant gel post-procedure, which have required surgical intervention in affected patients.

    Product
    ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0225-2023·2022-11-16

    ORISE Gel Syringe Recall Due to Foreign Body Reaction Risk

    Boston Scientific has recalled ORISE Gel Syringe kits used in gastrointestinal endoscopy due to higher incidence of foreign body reactions from remnant gel requiring surgical intervention.

    Product
    ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0223-2023·2022-11-16

    Neonatal Endotracheal Tube Grip with Detachable Metal Clips Recalled

    CooperSurgical is recalling NEO-fit Neonatal Endotracheal Tube Grips due to metal clips that can become loose or detach. Eleven complaints include three cases of clip ingestion, three removals from the mouth, and one throat laceration.

    Product
    NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0146-2023·2022-11-16

    Hammond's Salted Caramel Cookies Recalled for Undeclared Peanut Allergen

    Hammond's Salted Caramel Cookies contain an undeclared peanut allergen due to mispacking of Peanut Butter Chocolate Chip Cookies into Salted Caramel boxes. Nationwide distribution affected.

    Product
    Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6 91355 89889 5, Manufactured for: Hammond's Candies, 5735 Washington St, Denver, CO 80216. Cookies are packaged in sealed, opaque, white, plastic bag, which is packed inside printed on cardstock box. There are 8 boxes…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0224-2023·2022-11-16

    Medical Device Recall: ORISE Gel Submucosal Lifting Agent Due to Foreign Body Reactions

    Boston Scientific is recalling ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions to retained gel. These reactions caused mass formations requiring surgical intervention.

    Product
    ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Recalled for Infant Safety

    Cardinal Health is recalling its insulated gel pack because it should not be used on infants or neonates. The product labeling will be updated with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2023·2022-11-16

    Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access

    MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.

    Product
    Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-0222-2023·2022-11-16

    X-Guide X-Mark Probe Tool Recall: Missing Weld Creates Aspiration Risk

    X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.

    Product
    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2023·2022-11-16

    Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update

    iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.

    Product
    Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0191-2023·2022-11-16

    Cardinal Health insulated gel pack recalled for infant contraindication

    Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2023·2022-11-16

    Cardinal Health Insulated Gel Pack recalled; not safe for infants

    Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2023·2022-11-16

    FERNO POWER X1 ambulance cot batteries pose fire and burn risk

    Ferno-Washington is recalling 1,922 FERNO POWER X1 ambulance cots with 36V Li-Ion batteries that may become unstable and pose a fire or burn injury risk if dropped, power washed, or abused.

    Product
    FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates

    Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2023·2022-11-16

    Reusable gel pack recalled due to infant use contraindication

    Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Restricted for Infants

    Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.

    Product
    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2023·2022-11-16

    Canon Aplio Ultrasound Systems Software Defect May Misassign Patient Images

    Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.

    Product
    Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0182-2023·2022-11-16

    Sedecal Soltus Battery Mobile X-Ray Systems Recalled for Unintended Movement

    Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.

    Product
    Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0193-2023·2022-11-16

    Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerability

    Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.

    Product
    Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-0190-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Reusable Medium Contraindicated for Infant Use

    Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V846000·2022-11-16

    2022 Utilimaster Aeromaster Recalled for Incorrect Side-View Image Display

    Shyft Group is recalling 2022 Utilimaster Aeromaster vehicles because the side-view image may display the wrong side of the vehicle when the turn signal and brake are applied simultaneously.

    Product
    UTILIMASTER — UTILIMASTER AEROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Recalled for Unsafe Infant Use

    Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.

    Product
    Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
    Category
    Medical Device
    Distribution
    Distributed nationwide