The Recall Desk

State

Maine product recalls

72,986 recalls have nationwide distribution and so reach Maine. 3,894 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total
3,894
Critical
468
Severe
791
Most recent
2026-09-02

Of the 3,894 recalls naming Maine we have scored against our rubric, 468 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 791 (20%) are Severe.

These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6551–6575 of 76880

  • HighFDA (Devices)·Z-1801-2025·2025-05-28

    Philips Ingenia Ambition X MRI Systems Alignment Error in MobiView

    Philips is recalling certain Ingenia Ambition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2025·2025-05-28

    SmartPath to dStream 3.0T Medical Device Recall for Software Error

    Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.

    Product
    Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2025·2025-05-28

    TRUE 3D VIEWER SYSTEM displays medical images with incorrect orientation

    Echopixel's TRUE 3D VIEWER SYSTEM may display imaging data with incorrect orientation (left/right/superior/inferior/anterior/posterior), which could lead to inaccurate measurements during clinical use.

    Product
    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2025·2025-05-28

    Check-Flo Performer Introducer Medical Device Recall Notice

    Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.

    Product
    Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V352000·2025-05-28

    Mack Recalls 2026 Granite Trucks Due to Incorrect Brake Drum Load Ratings

    Mack Trucks is recalling 2026 Granite trucks because incorrect drive axle brake drums were installed, leading to inaccurate weight rating information on the door jamb label.

    Product
    MACK — MACK GRANITE GR (4)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2025·2025-05-28

    True 3D Viewer Model EP-00003 Software Orientation Display Issue Recall

    Echopixel's True 3D Viewer (Model EP-00003) with certain software versions can display ultrasound image orientation incorrectly, potentially leading to misdiagnosis or incorrect surgical planning.

    Product
    True 3D Viewer, Model: EP-00003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2025·2025-05-28

    SmartPath to Ingenia Elition X MRI Systems Alignment Error Recall

    Philips is recalling SmartPath to Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The alignment errors could affect image interpretation.

    Product
    Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2025·2025-05-28

    PhenoMATRIX bacterial culture plate interpretation software recalled nationwide

    Copan WASP is recalling PhenoMATRIX, an AI-powered bacterial culture plate interpretation software, because it lacks required FDA premarket approval, creating potential risk of inaccurate colony counts and morphology data that could affect patient diagnosis.

    Product
    PhenoMATRIX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2025·2025-05-28

    BD Cathena Safety IV Catheter manufacturing defect hole septum

    Becton Dickinson is recalling certain BD Cathena Safety IV Catheter models due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.

    Product
    BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2025·2025-05-28

    Ingenia Ambition S MRI devices recalled for alignment errors

    Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2025·2025-05-28

    Philips SmartPath to dStream Medical Imaging Software Alignment Error

    Philips is recalling SmartPath to dStream for XR and 3.0T medical imaging software due to potential alignment errors in cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1786-2025·2025-05-28

    Check-Flo Performer Introducer medical device recall for incorrect sheath sizing

    Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.

    Product
    Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2025·2025-05-28

    Ingenia 1.5T MRI Systems Recalled for Alignment Errors

    Philips is recalling Ingenia 1.5T MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.

    Product
    Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2025·2025-05-28

    Indomethacin Extended-Release Capsules Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2025·2025-05-28

    Ingenia 3.0T CX MRI System Alignment Error in Cross Reference Line

    Philips is recalling the Ingenia 3.0T CX MRI system due to potential alignment errors in the cross reference line when using the MobiView application to review images. The alignment error could affect image accuracy during review.

    Product
    Product Name: Ingenia 3.0T CX; Model Number: 781271;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1806-2025·2025-05-28

    Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect

    Smith & Nephew is recalling a Lag/Compression Screw Kit (REF: 71642690) because some compression screws have undersized hexagon sockets that render them non-functional and require replacement.

    Product
    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2025·2025-05-28

    Philips SmartPath to dStream 1.5T medical device alignment recall

    Philips is recalling certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1793-2025·2025-05-28

    Evolution Upgrade 1.5T imaging system alignment error recall

    Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via MobiView application.

    Product
    Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2025·2025-05-28

    Philips Upgrade to MR 7700 Medical Device Alignment Error Recall

    Philips is recalling the Upgrade to MR 7700 (Model 782130) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The misalignment could affect diagnostic accuracy.

    Product
    Product Name: Upgrade to MR 7700; Model Number: 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2025·2025-05-28

    MR 5300 Medical Device Recall for Cross Reference Line Alignment Error

    Philips is recalling MR 5300 medical devices (Model Numbers 782110 and 782152) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2025·2025-05-28

    Philips Ingenia Elition X MRI System Alignment Error Recall

    Philips has recalled specific Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2025·2025-05-28

    Philips Ingenia Elition S MRI System Alignment Error Recall

    Philips is recalling certain Ingenia Elition S MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1796-2025·2025-05-28

    Philips Ingenia 1.5T S MRI System Alignment Error Recall

    Philips is recalling the Ingenia 1.5T S magnetic resonance imaging (MRI) system due to potential alignment errors in cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia 1.5T S; Model Number: 781347;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0446-2025·2025-05-28

    Phentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide