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.

8276–8300 of 77014

  • HighFDA (Devices)·Z-0844-2025·2025-01-22

    Folysil Silicone Foley Catheters Recalled for Possible Sterility Issue

    Coloplast recalls Folysil Silicone Foley Catheters due to a possible sterility defect detected at the manufacturing facility. The affected units may not maintain proper sterilization, posing a risk of infection.

    Product
    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2025·2025-01-22

    Intuitive Surgical 8mm Cadiere Forceps Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 56,580 units of the 8mm Cadiere Forceps (Model 471049) due to increased complaints of frayed or broken grip cables on the reusable surgical instrument.

    Product
    8MM,CADIERE FORCEPS,IS4000 REF 471049
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0930-2025·2025-01-22

    Medical procedure kit recall due to sterile barrier packaging breach risk

    Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2025·2025-01-22

    ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues

    Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2025·2025-01-22

    Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2025·2025-01-22

    Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource surgical kits and dental packs are recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.

    Product
    Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2025·2025-01-22

    8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables

    Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0912-2025·2025-01-22

    Cardinal Health Laryngoscopy Presource Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling 512,786 Laryngoscopy Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the United States, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ; 5 ) STERILE LARYNGOSCOPY PACK, Cata
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0901-2025·2025-01-22

    Digoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference

    QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.

    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-0848-2025·2025-01-22

    Surgical Scissors Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 8MM Potts Scissors due to frayed or broken grip cables that could affect instrument performance during surgical procedures.

    Product
    8MM, POTTS SCISSORS, IS4000 REF 470001
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0867-2025·2025-01-22

    Intuitive Surgical Clip Applier Instruments Recalled for Frayed or Broken Cables

    Intuitive Surgical has recalled approximately 30,316 units of its 8MM Medium-Large Clip Applier instruments (Model 470327) due to reports of frayed or broken grip cables on the reusable surgical tools.

    Product
    8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0861-2025·2025-01-22

    HEM-O-LOK Clip Applier Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 29,559 units of the 8MM Large HEM-O-LOK Clip Applier for frayed or broken grip cables on the reusable surgical instrument jaws.

    Product
    8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0855-2025·2025-01-22

    Intuitive Surgical Recalls 8MM Micro Bipolar Forceps Due to Frayed Grip Cables

    Intuitive Surgical is recalling 178 units of its 8MM Micro Bipolar Forceps (Model 470171) due to increased complaints of frayed or broken grip cables on the reusable instruments. Affected devices have been distributed nationwide and internationally.

    Product
    8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0868-2025·2025-01-22

    Intuitive Surgical Bipolar Dissectors Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the reusable surgical instruments.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
    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-0951-2025·2025-01-22

    Sklar Instruments iris hooks recalled for sterile packaging integrity issues

    Sklar Instruments is recalling ECONO STERILE iris hook surgical kits due to packaging defects that may compromise sterile barrier integrity. No injuries reported.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2025·2025-01-22

    BD Pyxis MedStation ES software issue may delay medication dispensing

    A software bug in BD Pyxis MedStation ES medication dispensing cabinets may prevent staff from locating alternate supply locations, potentially delaying patient therapy.

    Product
    BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
    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-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-0936-2025·2025-01-22

    ECONO STERILE Medical Procedure Kits Recalled for Sterile Barrier Compromise

    Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0948-2025·2025-01-22

    Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues

    Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
    Category
    Medical Device
    Distribution
    Distributed nationwide