The Recall Desk

Hazard

Device Fracture recalls

63 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
63
Critical
7
Severe
30
Most recent
2026-07-01

Of the 63 device fracture recalls we have scored against our rubric, 7 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (48%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device fracture recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 63

  • HighFDA (Devices)·Z-1528-2020·2020-04-01

    Ev3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk

    Micro Therapeutics is recalling 762 Ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving parts in the patient.

    Product
    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2019·2019-06-12

    Stryker AXS Infinity LS Plus Long Sheath Recalled for Brittle Behavior

    Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheaths because a design issue can cause the device to become brittle and fracture.

    Product
    Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Lon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0605-2019·2018-12-19

    Howmedica Recalls Tritanium Posterior Lumbar Cage Implants Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.

    Product
    Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2016·2016-08-31

    Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture

    Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2620-2016·2016-08-31

    Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture

    Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.

    Product
    Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2617-2016·2016-08-31

    Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2016·2016-08-31

    Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets

    Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.

    Product
    FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for eva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2616-2016·2016-08-31

    Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets

    Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.

    Product
    Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2610-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2618-2016·2016-08-31

    Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture

    Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2613-2016·2016-08-31

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture

    Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.

    Product
    Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2614-2016·2016-08-31

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2016·2016-08-31

    Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture

    Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2611-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2612-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2621-2016·2016-08-31

    Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2623-2016·2016-08-31

    Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture

    Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0801-2016·2016-03-02

    Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0799-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Central Venous Catheter Sets

    Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.

    Product
    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture

    Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.

    Product
    Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2016·2016-03-02

    Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets

    Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2015·2014-12-24

    Stryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture

    Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench (Lot 4279) after a customer reported the device fractured during surgery.

    Product
    Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0582-2015·2014-12-17

    Skeletal Dynamics Recalls Align Radial Stems Due to Fracture Reports

    Skeletal Dynamics is recalling 1,700 Align Radial Stems because a report was received indicating the device fractured.

    Product
    Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and res
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2015·2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Replacement Pads

    Zimmer, Inc. is recalling 4,961 Trabecular Metal Tibial Impactor Replacement Pads due to complaints of pad fracture. The recall provides clarifying instructions for assembly and disassembly.

    Product
    Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0423-2015·2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Pads Due to Fracture Complaints

    Zimmer, Inc. is recalling Trabecular Metal Tibial Impactor Pads to provide clarifying instructions on assembly and disassembly following complaints of pad fracture.

    Product
    Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide