The Recall Desk

State

Montana product recalls

20,322 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.

12426–12450 of 20322

  • HighFDA (Devices)·Z-2131-2023·2023-07-19

    Medline PVP solution mislabeled as sterile when non-sterile

    Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2023·2023-07-19

    HeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function

    HeartSine battery and electrode cartridges for defibrillators may contain depleted battery cells, rendering them inoperable and preventing cardiac rhythm analysis or therapy delivery. Approximately 30,022 units are affected worldwide.

    Product
    HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implant Recall for Out-of-Spec Geometry

    Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2023·2023-07-19

    Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.

    Product
    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0918-2023·2023-07-19

    FDA Recalls Bivalirudin Injectable Drug Due to Particulate Matter

    Accord Healthcare is recalling Bivalirudin for Injection lot M2212070 due to the presence of fiber particles. Bivalirudin is an injectable blood thinner used in cardiac procedures.

    Product
    BIVALIRUDIN — BIVALIRUDIN (BIVALIRUDIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0897-2023·2023-07-19

    Sunmark and Generic Eye Drops Recalled for Manufacturing Deficiency

    K.C. Pharmaceuticals is recalling 341,568 bottles of Sunmark and generic tetrahydrozoline eye drops due to manufacturing practice deficiencies. The recall affects multiple brands distributed nationwide.

    Product
    SUNMARK EYE DROPS ORIGINAL FORMULA — SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2023·2023-07-19

    Medline Non-Sterile PVP Surgical Solution Kits Mislabeled as Sterile

    Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2120-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Geometry

    Medtronic is recalling 11 units of its Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification dimensions that could affect surgical fit and stability.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2023·2023-07-19

    Medline Non-Sterile PVP Solution Mislabeled as Sterile in Ophthalmic Kits

    Medline Industries is recalling 1,500 units of non-sterile PVP solution mislabeled as sterile in ophthalmic and eye surgical kits. Users may unknowingly apply non-sterile solution in eye procedures, risking infection.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0914-2023·2023-07-19

    FDA Recalls Tiagabine Hydrochloride Tablets Due to Impurity Specification Failures

    Sun Pharmaceutical is recalling Tiagabine Hydrochloride Tablets (2 mg) due to out-of-specification impurities detected during testing. The recall affects lot HAC3339A distributed nationwide.

    Product
    TIAGABINE HYDROCHLORIDE — TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2023·2023-07-19

    Surgical chest support device recalled for potential cracking at attachment

    Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.

    Product
    Allen Advance Chest Support with Pad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2023·2023-07-19

    Ambulance stretcher base leg assembly may bend causing tip and unstable motion

    Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.

    Product
    Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0907-2023·2023-07-19

    Fexofenadine Hydrochloride Tablets Recalled for Failed Purity Specifications

    L. Perrigo Company is recalling 15,504 cartons of Fexofenadine Hydrochloride 180 mg tablets nationwide due to failed impurity and degradation specifications.

    Product
    FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0913-2023·2023-07-19

    Sunitinib Malate Capsules Recalled Due to Excess Moisture Content

    Teva Pharmaceuticals is recalling 180 bottles of Sunitinib Malate Capsules due to moisture content exceeding approved specifications. The affected lot (100037220) expires 10/2024.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2023·2023-07-19

    Medline Non-Sterile PVP Solution Incorrectly Labeled as Sterile

    Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions

    Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2023·2023-07-19

    Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters

    Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.

    Product
    COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2023·2023-07-19

    Orthopedic Screw Recall Due to Undersized Head in Surgical Device

    Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.

    Product
    REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2023·2023-07-19

    Medtronic spinal implant recall due to out-of-specification device dimensions

    Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2023·2023-07-19

    Osteomed AutoDrive Screws Recalled for Undersized Screw Head

    Osteomed recalls orthopedic AutoDrive screws used in osteotomy procedures due to undersized screw heads that could pass through the mounting plate hole, potentially affecting surgical fixation.

    Product
    REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0903-2023·2023-07-19

    Allergy Relief Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications

    CVS Pharmacy is recalling 16,200 cartons of Allergy Relief fexofenadine hydrochloride tablets nationwide due to failed impurities and degradation specifications. Stop using affected lot 2DV1925 and consult a pharmacist.

    Product
    Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry

    Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0908-2023·2023-07-19

    Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications

    L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.

    Product
    GOOD SENSE ALLER EASE — GOOD SENSE ALLER EASE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2023·2023-07-19

    Medline Non-Sterile PVP Solution Mislabeled as Sterile

    Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
    Category
    Medical Device
    Distribution
    Distributed nationwide