The Recall Desk

State

Montana product recalls

72,986 recalls have nationwide distribution and so reach Montana. 3,568 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,568
Critical
689
Severe
783
Most recent
2026-09-16

Of the 3,568 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 783 (22%) are Severe.

These figures cover only the 3,568 recalls whose distribution notice names Montana specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7326–7350 of 76554

  • HighFDA (Drugs)·D-0284-2025·2025-03-26

    CVS Health Concealing Acne Treatment Cream Recalled for Benzene Contamination

    Fruit Of The Earth, Inc. is recalling CVS Health Concealing Acne Treatment Cream due to the presence of benzene, a chemical contaminant. The affected product was distributed nationwide.

    Product
    CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2025·2025-03-26

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.

    Product
    Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2025·2025-03-26

    C-Section Surgical Packs Recalled Over Sterilization Assurance Failure

    American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.

    Product
    C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2025·2025-03-26

    Medline C-Section Procedure Kits Recalled for Defective Syringes

    Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2025·2025-03-26

    Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed

    American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.

    Product
    OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2025·2025-03-26

    Delivery Pack Medical Device Sterilization Assurance Not Confirmed

    American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.

    Product
    DELIVERY PACK , Model No SGDV22D-01 SGDV22E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2025·2025-03-26

    Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.

    Product
    Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1354-2025·2025-03-26

    Diagnostic Neuro IR Tray recalled for unconfirmed sterilization

    American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.

    Product
    DIAGNOSTIC NEURO IR TRAY , Model No WENE21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2025·2025-03-26

    Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance

    American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.

    Product
    VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2025·2025-03-26

    Microstream CO2 Intubated Filter Lines Difficult to Disconnect

    Microstream CO2 filter lines used with intubated patients may be difficult or impossible to disconnect from the endotracheal tube, potentially delaying treatment or causing unintended extubation.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0283-2025·2025-03-26

    Walgreens Acne Cream Recalled for Benzene Contamination

    Walgreens Maximum Strength Tinted Acne Treatment Cream is being recalled for benzene contamination. The product was distributed nationwide; affected consumers should stop use immediately.

    Product
    Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.

    Product
    LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2025·2025-03-26

    CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure

    The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.

    Product
    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2025·2025-03-26

    DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2025·2025-03-26

    Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.

    Product
    BORN ON ARRIVAL KIT , Model No LLBN11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1373-2025·2025-03-26

    Hip Prosthetic Stem Recalled for Incorrect Product Code Label

    A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1371-2025·2025-03-26

    Helix Elite SARS-CoV-2 QC Material Recall Due to Potential Ct Value Issues

    Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.

    Product
    Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2025·2025-03-26

    IsoLoc Prostate Treatment Balloon Devices Recalled for Incorrect Fill Volume Labeling

    Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.

    Product
    IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2025·2025-03-26

    Modular Stem Orthopedic Implants Recalled for Incorrect GTIN Labeling

    Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2025·2025-03-26

    Access 2 Immunoassay Analyzer motor alignment issue may delay results

    Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.

    Product
    Access 2 Immunoassay Analyzer, Catalog Number 81600N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2025·2025-03-26

    Beckman Coulter DxI 9000 Analyzer Communication Failure Recall

    Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2025·2025-03-26

    Modular Stem Orthopedic Implant Recalled Due to Incorrect Product Identifier

    37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0288-2025·2025-03-26

    Medline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol

    Medline Industries has voluntarily recalled over 6.6 million alcohol prep pads nationwide because the product contains less isopropyl alcohol than labeled. The subpotent product was first reported on March 26, 2025.

    Product
    MEDLINE ALCOHOL PREP — MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0282-2025·2025-03-26

    Ciprofloxacin Ophthalmic Solution Recalled Nationwide for Defective Container Cap

    Ciprofloxacin Ophthalmic Solution is being recalled because the cap spike is lodged in the bottle nozzle, preventing patients from accessing the medication. Affected lot 084A067 was distributed nationwide.

    Product
    CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide