The Recall Desk

State

Montana product recalls

73,566 recalls have nationwide distribution and so reach Montana. 3,572 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,572
Critical
689
Severe
952
Most recent
2026-10-14

Of the 3,572 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 3,572 recalls whose distribution notice names Montana specifically. The 73,566 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

25601–25625 of 77138

  • SevereFDA (Devices)·Z-1537-2021·2021-06-16

    FDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution

    Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 7T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1784-2021·2021-06-16

    Adult Chest Tube Tray Recalled Due to Package Integrity Risk

    Avid Medical is recalling 130 Adult Chest Tube Trays due to potential contamination from mold growth in a component. The BD ChloraPrep applicator may grow Aspergillus penicillioides, which could breach package integrity and contaminate other kit components.

    Product
    ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0678-2021·2021-06-16

    Kroger Chicken Street Taco Kit Recalled for Undeclared Egg Allergen

    The Kroger Co. is recalling Chicken Street Taco kits because the Chipotle Crema component contains egg, which is not declared on the product label. This poses a risk to consumers with egg allergies.

    Product
    Chicken Street Taco kit in a plastic tray with a clear plastic lid.
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-1805-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate Screw Mechanism Failure Recall

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during surgery or unlock afterward. Eight units were distributed across 15 states.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2021·2021-06-16

    Laboratory Software Device May Produce Erroneous Results from Inadequate Instructions

    Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.

    Product
    Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate Screw Blocking Mechanism Disassociation Recall

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw blocking mechanism that may disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2021·2021-06-16

    Quanta System Sterile Optical Laser Fiber Recall for Potential Sterility Compromise

    Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.

    Product
    Quanta System Sterile Optical Laser Fiber, reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21151·2021-06-16

    Cove Appliance 24-inch Built-in Dishwashers Recalled for Fire Hazard

    Cove Appliance is recalling about 42,000 built-in dishwashers because the heating element can fail to shut off and overheat, creating a fire hazard. The company has received five reports of burning smells, flames, and smoking inside the dishwashers, though no injuries have been reported.

    Product
    Cove Appliance 24-inch built-in dishwashers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure

    Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure

    Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2021·2021-06-16

    Medical Device Software Defects in RayStation Treatment Planning System

    RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.

    Product
    RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential disassociation or postoperative unlock of the screw blocking mechanism during or after cervical spine surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2021·2021-06-16

    Anterior cervical plate system screw mechanism may disassociate during or after surgery

    Alphatec Spine's Atec Insignia Anterior Cervical Plate System has a potential defect where the screw blocking mechanism may disassociate during or after surgery, which could compromise spinal stabilization.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2021·2021-06-16

    Cervical Spine Plate System Screw Mechanism May Disassociate or Unlock

    Alphatec Spine recalls its Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism, which may disassociate or unlock during or after spinal surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2021·2021-06-16

    Alphatec Insignia Cervical Plate System: Screw Mechanism Disassociation Risk

    Alphatec recalls the Insignia Anterior Cervical Plate System due to risk that the screw blocking mechanism may disassociate during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine recalls Atec Insignia Anterior Cervical Plate Systems because the screw blocking mechanism may fail during or after surgery. The mechanism may disassociate or unlock, potentially compromising implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2021·2021-06-16

    FDA Recalls Olympus Sterile Optical Laser Fibers for Potential Sterility Compromise

    Quanta System is recalling Olympus Sterile Optical Laser Fibers nationwide due to potentially compromised sterility. Approximately 26,925 units distributed through six U.S. distributors are affected.

    Product
    Olympus Sterile Optical Laser Fiber, single use and reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2021·2021-06-16

    Anterior Cervical Plate System Recalled for Potential Screw Mechanism Failure

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after cervical spine surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2021·2021-06-16

    Radiotherapy positioning software may delay patient movement display

    Brainlab's ExacTrac Dynamic radiotherapy positioning software may delay display of patient movement during high-dose treatments, risking treatment precision errors. 22 systems affected across 11 U.S. states.

    Product
    ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Disassociate or Unlock

    Alphatec Spine recalls its Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during spinal surgery or unlock afterward. Healthcare providers should contact the manufacturer for guidance.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2021·2021-06-16

    Anterior cervical plate system screw blocking mechanism defect recalled

    Alphatec Spine's Atec Insignia anterior cervical plate system has a defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2021·2021-06-16

    Anterior cervical plate system screw blocking mechanism may disassociate

    Alphatec Spine Inc. is recalling the Atec Insignia anterior cervical plate system because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No injuries reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2021·2021-06-16

    Anterior cervical plate system screw mechanism may disassociate or unlock

    The Alphatec Insignia anterior cervical plate system may have a defect where the screw blocking mechanism disassociates during surgery or unlocks afterward. Consult your doctor if you have this implant.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate System screw locking mechanism failure

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw locking mechanism. The mechanism may disassociate or unlock during or after spinal surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
    Category
    Medical Device
    Distribution
    Distributed nationwide