The Recall Desk

State

Montana product recalls

73,198 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 73,198 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

14401–14425 of 76769

  • HighNHTSA·23V709000·2023-10-19

    2023 Jaguar I-PACE vehicles recalled for battery fire risk

    Jaguar is recalling 2019-2023 I-PACE vehicles due to battery overheating risk from an incomplete prior repair. Owners must park and charge outside until the software update is installed and for 30 days after.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V701000·2023-10-19

    Alliance RV fifth wheel trailers recalled for loose solar electrical connection

    Alliance RV is recalling 2021-2023 Paradigm and Valor fifth wheel trailers because a wire connector in the solar panel electrical system may loosen and overheat, creating a fire risk.

    Product
    ALLIANCE RV — ALLIANCE RV PARADIGM, VALOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0028-2024·2023-10-18

    FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching

    Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.

    Product
    2008T Hemodialysis SYS, with CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0034-2024·2023-10-18

    Hemodialysis machines recalled due to potential circuit board material leaching

    Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.

    Product
    2008T HD SYS. W/O CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0035-2024·2023-10-18

    Hemodialysis Systems Recalled for Potential PCBA Tubing Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.

    Product
    2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0029-2024·2023-10-18

    Hemodialysis machines recalled for potential printed circuit board contamination

    Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.

    Product
    2008T Hemodialysis System without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2024·2023-10-18

    10ML Syringe Luer Lock Recalled for Potential Blood Backfill Leakage

    Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.

    Product
    10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0033-2024·2023-10-18

    Hemodialysis machines recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.

    Product
    2008T HD SYS. CDX W/BIBAG BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0031-2024·2023-10-18

    Medical device manufacturer recalls hemodialysis machines for potential PCBA leaching

    Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.

    Product
    2008T GEN 2 Bibag without CDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2024·2023-10-18

    FDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material

    Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.

    Product
    10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2024·2023-10-18

    FDA recalls BREXAFEMME tablets due to cross-contamination with ezetimibe

    The FDA is recalling BREXAFEMME antifungal tablets due to potential cross-contamination with ezetimibe during manufacturing, with two lot numbers distributed nationwide.

    Product
    BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0030-2024·2023-10-18

    2008T Hemodialysis System recalled for potential PCBA leaching from tubing

    Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.

    Product
    2008T Hemodialysis System w/Bibag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2024·2023-10-18

    Syringes with Luer Lock Recalled for Blood Backfill and Foreign Material Risk

    Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.

    Product
    3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2024·2023-10-18

    Hemodialysis Machines Recalled Due to Potential PCBA Leaching

    Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.

    Product
    2008T HD SYS. CDX BLUESTAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs With Recalled Components

    Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2024·2023-10-18

    Knee Tibial Insert Recalled Due to Component Mix-Up in Packaging

    Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2024·2023-10-18

    Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use

    The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.

    Product
    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2024·2023-10-18

    RoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization

    RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.

    Product
    CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0076-2024·2023-10-18

    Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift

    The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.

    Product
    Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V700000·2023-10-18

    BMW 750e and multiple 2023-2024 models recalled for steering wheel sensor defect

    BMW is recalling certain 2023-2024 models including the 750e due to a faulty ground connection in the steering wheel electrical system. The defect may render the hands-on detection system inoperative, preventing the emergency stopping assistant from engaging and increasing crash risk.

    Product
    BMW — BMW 740I, I5, I7, I7 M70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2024·2023-10-18

    Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall

    Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.

    Product
    Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2024·2023-10-18

    Multichem control vials break during shipping or thawing due to glass defect

    TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.

    Product
    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2024·2023-10-18

    Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms

    Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.

    Product
    Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2024·2023-10-18

    BD Pyxis CII Safe ES Software Flaw Disables Controlled Substance Safeguards

    Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.

    Product
    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
    Category
    Medical Device
    Distribution
    Distributed nationwide