The Recall Desk

State

Maine product recalls

73,092 recalls have nationwide distribution and so reach Maine. 3,922 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total
3,922
Critical
478
Severe
803
Most recent
2026-09-23

Of the 3,922 recalls naming Maine we have scored against our rubric, 478 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 803 (20%) are Severe.

These figures cover only the 3,922 recalls whose distribution notice names Maine specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8251–8275 of 77014

  • HighFDA (Devices)·Z-0863-2025·2025-01-22

    8MM Dual Blade Retractors recalled for frayed or broken grip cables

    Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. and internationally.

    Product
    8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0860-2025·2025-01-22

    Intuitive Surgical Tenaculum Forceps Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.

    Product
    8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0944-2025·2025-01-22

    Gynecological Speculum Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE gynecological speculum kits due to packaging issues that may compromise sterility. No injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2025·2025-01-22

    Sklar Instruments Recalls Sterile Vein Hooks Due to Packaging Issues

    Sklar Instruments is recalling 1,050 units of ECONO STERILE Vein Hooks due to packaging issues that may breach the sterile barrier. Products were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2025·2025-01-22

    Intuitive Surgical Fenestrated Grasper Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.

    Product
    8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0851-2025·2025-01-22

    Intuitive Surgical Micro Forceps Recalled Due to Grip Cable Defects

    Intuitive Surgical is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to complaints of frayed or broken grip cables. The defect affects 1,111 units distributed nationwide and internationally.

    Product
    8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0876-2025·2025-01-22

    8MM Maryland Bipolar Forceps Recalled for Frayed Grip Cable

    Intuitive Surgical is recalling 68,458 units of its 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on the reusable surgical instruments.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0866-2025·2025-01-22

    Surgical Retractor Instruments Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.

    Product
    8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0933-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Surgical Retractors Due to Packaging Issues

    Sklar Instruments is recalling 1,050 ECONO STERILE surgical retractors nationwide due to packaging defects that may compromise sterility. The affected kits have potential breaches in their sterile barriers.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2025·2025-01-22

    Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk

    Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.

    Product
    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2025·2025-01-22

    Tenaculum Forceps for da Vinci Surgical Systems Recalled Due to Pitch Cable Failures

    Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.

    Product
    8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2025·2025-01-22

    Intuitive Surgical Clip Applier Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.

    Product
    8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0878-2025·2025-01-22

    Fenestrated Bipolar Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 147,006 units of 8MM Fenestrated Bipolar Forceps due to increased complaints of frayed or broken grip cables, which could impair surgical control.

    Product
    8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0958-2025·2025-01-22

    Change Healthcare Cardiology Hemo software autosave defect recall

    A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.

    Product
    Change Healthcare Cardiology Hemo software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2025·2025-01-22

    VITROS DGXN Slides Recalled Due to Hemoglobin Interference in Digoxin Measurement

    VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2025·2025-01-22

    8MM Large Suturecut Needle Driver Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 8MM Large Suturecut Needle Driver instruments due to frayed or broken grip cables. The recall affects 784 units distributed nationwide and internationally.

    Product
    8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0947-2025·2025-01-22

    ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues

    Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach the sterile barrier.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2025·2025-01-22

    ECONO STERILE medical procedure kits recalled for potential sterile barrier breach

    Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2025·2025-01-22

    Change Healthcare Cardiology Software Defect May Cause Incorrect Medication Administration

    A software defect in Change Healthcare's Cardiology Hemodynamics software may cause clinicians to administer incorrect medications. The defect affects an autosave mechanism and has been distributed nationwide and internationally.

    Product
    Change Healthcare Cardiology Hemodynamics software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2025·2025-01-22

    Intuitive Surgical Bipolar Dissector Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 8MM curved bipolar dissectors due to frayed or broken grip cables that could affect surgical instrument performance. Approximately 3,869 units were distributed nationwide and internationally.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0928-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Gynecological Procedure Kits for Packaging Defects

    Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2025·2025-01-22

    ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk

    Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2025·2025-01-22

    Intuitive Surgical DeBakey Forceps Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.

    Product
    8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0956-2025·2025-01-22

    Murata Vios Cardiac Monitor Model 2050 Displays Distorted and Flickering Waveforms

    The muRata Vios Monitoring System Model 2050 central station monitor can display distorted and flickering ECG waveforms and vital signs. The issue affects only the central station display, not the bedside monitor or patient monitoring accuracy.

    Product
    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
    Category
    Medical Device
    Distribution
    Distributed nationwide