The Recall Desk

State

Hawaii product recalls

73,092 recalls have nationwide distribution and so reach Hawaii. 2,770 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,770
Critical
333
Severe
569
Most recent
2026-09-23

Of the 2,770 recalls naming Hawaii we have scored against our rubric, 333 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 569 (21%) are Severe.

These figures cover only the 2,770 recalls whose distribution notice names Hawaii specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8201–8225 of 75862

  • 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-0837-2025·2025-01-22

    Karl Storz Biopsy and Grasping Forceps Recalled Due to Sterility Validation Failure

    Karl Storz Endoscopy is recalling 285 units of optical biopsy and grasping forceps (REF 723400) distributed across 31 US states due to failure of manual cleaning validation, which compromises sterility assurance.

    Product
    Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0952-2025·2025-01-22

    Orthopedic Surgery Kits Recalled for Potential Sterile Barrier Packaging Defects

    Sklar Instruments is recalling ECONO STERILE LEMPERT BONE RONG orthopedic surgery kits due to packaging defects that may compromise sterility. The affected kits (Model 96-4780A, Lot HSI) were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0203-2025·2025-01-22

    Prescription Drug Cardura Recalled for Specification Failures in Manufacturing

    Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.

    Product
    CARDURA — CARDURA (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2025·2025-01-22

    PROPONENT DR Pacemaker Recalled for Unexpected Safety Mode Risk

    Boston Scientific is recalling certain PROPONENT DR pacemakers built before September 2018 due to latent battery impedance that could cause unexpected Safety Mode initiation during normal operation.

    Product
    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2025·2025-01-22

    Surgical instrument kits recalled for potential sterile packaging defects

    Sklar Instruments is recalling 41,850 units of ECONO STERILE surgical procedure kits due to packaging defects that may compromise the sterile barrier, affecting multiple clamp and hemostat models used in general orthopedic surgery.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2025·2025-01-22

    Cardinal Health Fetal Surgery Kits Recalled for Endotoxin Contamination Risk

    Cardinal Health is recalling Presource fetal surgery kits due to potential endotoxin contamination in non-sterile surgical strips and patties, which could pose infection risk.

    Product
    Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V027000·2025-01-22

    Starcraft Bus Recalls 2023-2024 Models for Emergency Exit Handle Issues

    Forest River is recalling 2023-2024 Starcraft Starlite and Allstar buses because emergency exit handles are not easily accessible, potentially delaying passenger evacuation.

    Product
    STARCRAFT BUS — STARCRAFT BUS ALLSTAR, STARLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2025·2025-01-22

    ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues

    Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.

    Product
    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2025·2025-01-22

    Surgical Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.

    Product
    8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0916-2025·2025-01-22

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The recall affects 512,786 units distributed worldwide.

    Product
    Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2025·2025-01-22

    Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation

    Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.

    Product
    Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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-0872-2025·2025-01-22

    Reusable Surgical Forceps Recall Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 1,562 units of 8mm surgical forceps (Model 471048) due to complaints of frayed or broken grip cables. The defect could impair instrument function during use.

    Product
    8MM,LONG TIP FORCEPS,IS4000 REF 471048
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0859-2025·2025-01-22

    Intuitive Surgical Recalls Fenestrated Bipolar Forceps Over Frayed Grip Cables

    Intuitive Surgical recalls 8MM Fenestrated Bipolar Forceps due to increased complaints about frayed or broken grip cables on 12,340 units distributed nationwide and internationally.

    Product
    8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0862-2025·2025-01-22

    Surgical Retractor Grip Cables May Fray or Break During Use

    Intuitive Surgical is recalling 738 units of the 8MM Atrial Retractor (Model 470246) due to reports of frayed or broken grip cables on reusable instruments. The defect could compromise instrument performance during surgical procedures.

    Product
    8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0874-2025·2025-01-22

    ProGrasp Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical recalls ProGrasp Forceps instruments due to increased complaints of frayed or broken grip cables. Approximately 99,249 units distributed in the U.S. and internationally are affected.

    Product
    8MM,PROGRASP FORCEPS,IS4000 REF 471093
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0845-2025·2025-01-22

    X-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect

    Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.

    Product
    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2025·2025-01-22

    Gynecological dilator kits recalled for potential sterile barrier compromise

    Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE
    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-0939-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Medical Procedure Kits for Sterile Barrier Breach Risk

    Sklar Instruments is recalling 245,015 ECONO STERILE medical procedure kits nationwide due to packaging issues that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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