The Recall Desk

State

Maine product recalls

20,199 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.

About recalls in Maine

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 Maine 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.

10251–10275 of 20199

  • HighFDA (Devices)·Z-0993-2024·2024-02-14

    FilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2024·2024-02-14

    RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk

    Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.

    Product
    BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2024·2024-02-14

    Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns

    BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.

    Product
    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2024·2024-02-14

    Amneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity

    Amneal Pharmaceuticals is recalling Phenoxybenzamine Hydrochloride Capsules, 10mg, due to an unknown impurity. The recall affects 858 bottles distributed nationwide.

    Product
    Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2024·2024-02-14

    BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.

    Product
    BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2024·2024-02-14

    Flow-i C20 Anesthesia System cybersecurity vulnerability could enable remote attacks

    The Flow-i C20 Anesthesia System has a cybersecurity vulnerability allowing potential remote access, denial of service attacks, or code execution. Healthcare facilities should contact the manufacturer for patches and guidance.

    Product
    Flow-i C20 Anesthesia System, model 6677200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2024·2024-02-14

    Laboratory Analyzer Software Bug Could Produce Erroneous Clinical Test Results

    Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.

    Product
    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2024·2024-02-14

    BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2024·2024-02-14

    BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis

    Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2024·2024-02-14

    BD BBL Sensi Disc Ceftriaxone Test Discs Recalled for Susceptibility Testing Accuracy Issues

    BD BBL Sensi Disc Ceftriaxone susceptibility test discs may have accuracy and quality control failures. These defects could lead to delayed diagnosis or incorrect antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2024·2024-02-14

    Antibiotic susceptibility test discs recalled for accuracy and quality failures

    Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0288-2024·2024-02-14

    Omeza Lidocaine Lavage pain relief oil recalled for manufacturing practice violations

    OMEZA LLC has recalled Omeza Lidocaine Lavage pain relief oil (4,390 vials) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on January 19, 2024.

    Product
    Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2024·2024-02-14

    BD BBL Sensi Disc Levofloxacin Testing Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling 2,363,168 units of BD BBL Sensi Disc Levofloxacin testing discs (Catalog No. 231705, 231706) due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2024·2024-02-14

    BD BBL clarithromycin susceptibility test discs recalled for accuracy and quality failures

    Becton Dickinson recalls BD BBL Sensi Disc Clarithromycin-15 ug susceptibility testing discs due to accuracy and reproducibility failures that may produce inaccurate test results in clinical laboratories.

    Product
    BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2024·2024-02-14

    RX Series Copper Assay Requires Modified Testing Order

    Randox Laboratories issued a technical bulletin stating that RX Series Copper Assay tests must not be run directly after Total Protein tests, as this could produce falsely elevated copper results.

    Product
    RX Series Copper (Cu) Assay Ref. Number CU2340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2024·2024-02-14

    Barco MDSC-8527 NXF Medical Display decoder functionality blocked

    Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in New Jersey.

    Product
    Barco MDSC-8527 NXF, Part Number K9352421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2024·2024-02-14

    BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2024·2024-02-14

    RotaFlow Centrifugal Pump sterile barrier defect FDA Class II recall

    RotaFlow Centrifugal Pumps have potential seal defects that could compromise sterile barriers, risking infection in cardiac bypass patients. FDA recommends device identification and contact with manufacturer for remediation.

    Product
    BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2024·2024-02-14

    BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures

    Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2024·2024-02-14

    Water Filter MAJ-2318 May Be Incorrectly Assembled, Risking Infection

    Olympus MAJ-2318 water filters may be assembled incorrectly, allowing unfiltered tap water to contaminate reprocessed endoscopes and expose patients to infection risk.

    Product
    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2024·2024-02-14

    Flow-c Anesthesia System cybersecurity vulnerability in 14 units

    The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.

    Product
    Flow-c Anesthesia System, model 6887700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2024·2024-02-14

    Cefotaxime antibiotic susceptibility test discs recalled for potential testing accuracy failures

    BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.

    Product
    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2024·2024-02-14

    BD antibiotic susceptibility test discs recalled for possible accuracy failures

    BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2024·2024-02-14

    Medical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect

    Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.

    Product
    Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0856-2024·2024-02-14

    Popcorn Pre-Pop Recalled Due to Undeclared Yellow #5 Dye

    County Fair Foods is recalling 42,000 bags of Popcorn Pre-Pop nationwide due to undeclared Yellow #5 dye. The voluntary recall was initiated because Yellow #5 was not declared on the product label.

    Product
    Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to a case
    Category
    Food
    Distribution
    Distributed nationwide