The Recall Desk

State

Massachusetts product recalls

72,992 recalls have nationwide distribution and so reach Massachusetts. 8,211 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,211
Critical
1,171
Severe
2,013
Most recent
2026-09-16

Of the 8,211 recalls naming Massachusetts we have scored against our rubric, 1,171 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,013 (25%) are Severe.

These figures cover only the 8,211 recalls whose distribution notice names Massachusetts specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8451–8475 of 81203

  • 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-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-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-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-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-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-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-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-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-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-0924-2025·2025-01-22

    FDA Recalls Small Graptor Retractor Instruments Due to Cable Failures

    Intuitive Surgical is recalling 42,028 Small Graptor surgical retractor instruments used with da Vinci X/Xi systems due to pitch cable failures. The recalled devices affect surgical facilities nationwide and internationally.

    Product
    8MM, Small Graptor REF 470318 Is a grasping retractor 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-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
  • HighFDA (Devices)·Z-0949-2025·2025-01-22

    Sklar Instruments ECONO STERILE surgical procedure kits recalled due to packaging defect

    Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits nationwide due to packaging issues that may breach the sterile barrier.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
    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-0961-2025·2025-01-22

    VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance

    Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.

    Product
    VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2025·2025-01-22

    Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk

    Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.

    Product
    Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0907-2025·2025-01-22

    Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results

    Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.

    Product
    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0945-2025·2025-01-22

    Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects

    Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0918-2025·2025-01-22

    Portrait Core Services Software Loss of Patient Monitoring After 425 Days

    A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.

    Product
    Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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