The Recall Desk

State

Montana product recalls

73,088 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 73,088 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9226–9250 of 76659

  • HighFDA (Devices)·Z-0270-2025·2024-11-06

    Laryngeal Tube Device Recalled for Unapproved Pediatric Indication

    King Systems Corp. is recalling 21,939 KING LTSD laryngeal tubes nationwide because the device was marketed for pediatric use without proper FDA regulatory clearance. The device was originally approved only for adult use.

    Product
    KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2025·2024-11-06

    Hospital Bed Fails to Send Remote Alerts Through Nurse Call System

    Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.

    Product
    a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0273-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Use

    King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.

    Product
    KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2025·2024-11-06

    Ambu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk

    Ambu is recalling VivaSight 2 DLT endotracheal tubes due to hyper angulation of the distal end, which increases risk of intubation complications and airway injury.

    Product
    Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2025·2024-11-06

    Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.

    Product
    SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2025·2024-11-06

    Integra Recalls Surgical Patties and Strips Due to Endotoxin Levels

    Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.

    Product
    SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.

    Product
    SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2025·2024-11-06

    Nihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance

    Nihon Kohden America Inc. is recalling 64 Adult Ear Clip SpO2 Sensors (Model 809030007) due to lack of FDA market approval and clearance for U.S. distribution.

    Product
    Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Drugs)·D-0027-2025·2024-11-06

    Cinacalcet tablets recalled for nitroso impurity above FDA limits

    Dr. Reddy's Laboratories is recalling Cinacalcet 60 mg tablets nationwide because testing detected N-nitroso impurity exceeding FDA interim limits. The recall affects 35,880 bottles.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2025·2024-11-06

    Thyroglobulin Antibody Assay Instructions Incorrectly State Biotin Interference Resolution

    Beckman Coulter is recalling over 465,000 thyroglobulin antibody test kits because their instructions incorrectly state that biotin interference was addressed. The false information could lead to false-low test results.

    Product
    Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2025·2024-11-06

    Codman Surgical Patties Recalled for Endotoxin Contamination

    Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips due to endotoxin contamination in raw material that may result in out-of-spec finished products. The devices protect tissue during surgery, including the brain.

    Product
    SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2025·2024-11-06

    Codman Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences has recalled Codman Surgical Patties and Strips (Model 801407) due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification endotoxin in finished products used in brain surgery.

    Product
    SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801452) due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination. Approximately 4,818 units are affected.

    Product
    SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0276-2025·2024-11-06

    KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use

    King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0272-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation

    King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0271-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Exemption

    King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD Oropharyngeal Airways due to exceeding 510(k) exemption limitations.

    Product
    KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V836000·2024-11-05

    2024-2025 Lucid Air vehicles recalled for wiring harness defect

    Lucid is recalling 2024-2025 Air models due to a rear subframe wiring harness that may be too short, causing power loss to the rear drive unit and increasing crash risk. Replacement is free.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V832000·2024-11-05

    2024 Tesla Cybertruck drive inverter fault may cause power loss

    Tesla is recalling 2024 Cybertruck vehicles due to a drive inverter fault that may cause loss of propulsion. Affected owners will receive a free inverter replacement.

    Product
    TESLA — TESLA CYBERTRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V647000·2024-11-05

    Nova Bus LFS Vehicles Recalled for Faulty Seat Belt Retraction

    Nova Bus is recalling certain 2010-2024 LFS buses because the driver's seat belt may not retract properly. This can result in a loose seat belt, increasing the risk of injury in a crash.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V830000·2024-11-04

    International Recalls 2024-2025 HX Trucks for Axle Hub Lubricant Defect

    International is recalling 2024-2025 HX vehicles because insufficient lubricant in front axle hubs may damage wheel bearings, potentially causing wheel separation and loss of control.

    Product
    INTERNATIONAL — INTERNATIONAL HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V829000·2024-11-04

    2025 BMW X1 B-Pillar Structure Defect May Reduce Crash Protection

    Certain 2025 BMW X1 vehicles have B-Pillar reinforcement plates with insufficient structural strength. This defect may reduce crash protection and increase injury risk.

    Product
    BMW — BMW X1
    Category
    Vehicle
    Distribution
    Distributed nationwide