The Recall Desk

State

Maine product recalls

20,096 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.

7376–7400 of 20096

  • HighFDA (Devices)·Z-3259-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug units expire before labeled date

    Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3265-2024·2024-10-02

    Esophageal stent system recalled due to potential delivery catheter detachment

    Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.

    Product
    WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3194-2024·2024-10-02

    Philips Ingenia 1.5T MRI Device Recall: Loose Screws May Block Tabletop

    Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.

    Product
    Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3260-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration

    Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3251-2024·2024-10-02

    Cook Biotech Fistula Plug recalled for expiring before labeled date

    Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.

    Product
    Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2024·2024-10-02

    MRI Diagnostic Device Screws May Loosen, Block Tabletop

    Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.

    Product
    SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2024·2024-10-02

    Custom Procedure Kit Sheath Introducers Mislabeled by Size

    Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.

    Product
    Custom Procedure Kit, REF: K12T-11077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3243-2024·2024-10-02

    Medical device kit recalled due to inability to confirm sterilization assurance

    American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.

    Product
    Cysto, FTCY03L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3286-2024·2024-10-02

    WallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3235-2024·2024-10-02

    IR Procedure Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.

    Product
    IR Procedure Pack, CEAT19W; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3246-2024·2024-10-02

    BD Phoenix M50 may misidentify E. coli bacteria in clinical samples

    The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.

    Product
    BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3280-2024·2024-10-02

    FDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.

    Product
    WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3198-2024·2024-10-02

    Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws

    Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.

    Product
    Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3199-2024·2024-10-02

    MRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment

    Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.

    Product
    Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3282-2024·2024-10-02

    Boston Scientific recalls WallFlex and Agile esophageal stents for delivery catheter detachment

    Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.

    Product
    WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3276-2024·2024-10-02

    Boston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment

    Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.

    Product
    WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3285-2024·2024-10-02

    Esophageal Stent System Recalled Due to Potential Catheter Tip Detachment

    Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3252-2024·2024-10-02

    Biodesign Fistula Plug recalled for expiring before printed expiration date

    Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.

    Product
    Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3272-2024·2024-10-02

    Esophageal stent systems recalled due to delivery catheter tip detachment risk

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.

    Product
    WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3244-2024·2024-10-02

    Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue

    American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.

    Product
    Pacemaker, COPM11B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3193-2024·2024-10-02

    MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk

    Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.

    Product
    Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3221-2024·2024-10-02

    Medical endoscope recalled for unapproved sterilization instructions

    Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.

    Product
    Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0665-2024·2024-10-02

    Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach

    Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.

    Product
    Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3247-2024·2024-10-02

    BD Phoenix diagnostic systems may misidentify E. coli in clinical samples

    The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.

    Product
    BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3257-2024·2024-10-02

    Biodesign Fistula Plug implants recalled for premature expiration defect

    Cook Biotech is recalling 130 units of Biodesign Fistula Plug C-FPS-0.7-2 surgical implants because the devices expire prior to the expiration date printed on the labeling. Devices were distributed worldwide including the US and 11 other countries.

    Product
    Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
    Category
    Medical Device
    Distribution
    Distributed nationwide