The Recall Desk

State

Colorado product recalls

72,992 recalls have nationwide distribution and so reach Colorado. 6,941 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,941
Critical
1,218
Severe
1,507
Most recent
2026-09-09

Of the 6,941 recalls naming Colorado we have scored against our rubric, 1,218 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,507 (22%) are Severe.

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8376–8400 of 79933

  • 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-0847-2025·2025-01-22

    Intuitive Surgical Monopolar Curved Scissors Recalled for Frayed Grip Cables

    Intuitive Surgical recalls 355,547 monopolar curved scissors due to increased complaints of frayed or broken grip cables on these reusable surgical instruments.

    Product
    8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0931-2025·2025-01-22

    Medical Procedure Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
    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-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-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-0941-2025·2025-01-22

    Sklar Instruments Sterile Surgical Kits Recalled for Packaging Defects

    Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0908-2025·2025-01-22

    Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses have been reported.

    Product
    Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2025·2025-01-22

    Intuitive Surgical Needle Driver Recall Due to Grip Cable Failures

    Intuitive Surgical is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical use.

    Product
    8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
    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-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-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-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-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-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-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-0940-2025·2025-01-22

    ECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk

    Sklar Instruments is recalling ECONO STERILE medical procedure kits (Model 96-4921A) due to packaging issues that may result in a breach of the sterile barrier. The kits should not be used.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
    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-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-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