The Recall Desk

Hazard

Fracture recalls

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

What the numbers show

Total
160
Critical
4
Severe
83
Most recent
2026-07-29

Of the 160 fracture recalls we have scored against our rubric, 4 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 83 (52%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all 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.

1–25 of 160

  • HighFDA (Devices)·Z-2770-2026·2026-07-29

    Penumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk

    Penumbra, Inc. is recalling its RED 68 Reperfusion Catheter due to manufacturing issues that may cause the device to fracture during use.

    Product
    Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2026·2026-05-27

    Tangent Single Use Digital Catheter Recalled for Distal Shaft Fractures

    Tangent Endoscopy is recalling its Tangent Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk) due to fractures observed at the distal shaft tip without complete detachment, posing a risk during endoscopic procedures.

    Product
    Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V075000·2026-02-09

    Harley-Davidson Sportster S upper triple clamp may fracture during use

    Harley-Davidson is recalling certain 2021-2026 RH1250S Sportster S motorcycles because the upper triple clamp may fracture, which can lead to a loss of control.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON RH1250S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25431·2025-08-14

    Werner Multi-Max Pro ladder locking mechanisms can jam without fully locking

    Werner 20' and 24' Multi-Max Pro multi-purpose ladders are being recalled because the locking mechanism can jam and not fully lock. Eighteen falls and fourteen injuries reported. About 122,250 units affected.

    Product
    Werner 20' and 24' Multi-Max Pro Multi-Purpose Ladders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25253·2025-05-08

    Igloo 90 Qt. Rolling Coolers Recalled for Fingertip Amputation Risk

    Igloo has expanded its recall of 90 Qt. Flip & Tow Rolling Coolers due to tow handle pinching hazards that can cause fingertip amputation or crushing injuries. About 130,000 additional coolers manufactured prior to January 2024 are affected.

    Product
    Igloo 90 Qt. Flip & Tow Rolling Coolers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2025·2025-03-19

    Z1 Femoral Hip System Recalled Over Stem Inserter Design Issue

    Zimmer, Inc. is recalling 35 units of the Z1 Femoral Hip System due to a potential design issue with the Z1 Offset Stem Inserter that could cause fracturing of the distal tip.

    Product
    Z1 Femoral Hip System, Product Number 611777612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V878000·2024-11-21

    Toyota Corolla steering intermediate shafts may fracture and detach

    Toyota is recalling certain 2023-2024 Corolla and Corolla Hybrid vehicles because manufacturing cracks may cause the steering intermediate shaft to fracture and detach.

    Product
    TOYOTA — TOYOTA COROLLA, COROLLA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2025·2024-11-20

    Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness

    Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.

    Product
    Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2024·2024-07-10

    Surgical retractor blade manufacturing defect could cause bone fracture

    SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2024·2024-05-08

    Zirconium oxide dental blocks recalled for cracking risk

    IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.

    Product
    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1284-2024·2024-03-20

    Vascular guide catheter recalled due to distal end fracture risk

    Medos is recalling CERENOVUS CEREBASE DA Guide Sheaths due to reports of fractures at the distal end. Fractures may delay surgical procedures or cause vascular injury.

    Product
    CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1167-2024·2024-02-28

    ESG Cutting Forceps Jaw May Fracture During Use or Inspection

    Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.

    Product
    ESG PK CUTTING FORCEPS, 5MM, 33CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2024·2024-02-14

    BrightView Gamma Camera Detector May Fall and Injure Patients

    Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.

    Product
    BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0931-2024·2024-02-14

    Gamma Camera Detector May Fall Due to Component Failure

    The detector in Philips BrightView XCT gamma cameras may fall unexpectedly due to component failure. If it falls below the center of the gantry, it could cause abrasion, contusion, laceration, or fracture to patients' lower limbs.

    Product
    BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2024·2024-01-17

    Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance

    Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.

    Product
    BrightView X, Gamma Camera, Product Code 882478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2024·2024-01-17

    Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard

    Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.

    Product
    BrightView, Gamma Camera System, Product Code 882480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2024·2024-01-17

    Gamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard

    Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.

    Product
    BrightView XCT, Gamma Camera, Product Code 882482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2218-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion

    Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.

    Product
    TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2023·2023-05-24

    Spectral CT X-Ray System Foot Switch May Entrap Operator's Foot

    The Spectral CT 7500 foot switch unload pedal may entrap an operator's foot, risking injuries including fracture and dislocation. Philips is recalling 92 units with worldwide distribution.

    Product
    Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·23201·2023-05-11

    Peloton Exercise Bikes Recalled for Seat Post Breakage and Fall Risk

    Peloton is recalling approximately 2.2 million Model PL01 exercise bikes because the seat post assembly can break during use, causing users to fall. The company has received 35 reports of seat post breakage, including 13 reports of injuries such as fractured wrists, lacerations, and bruises.

    Product
    Peloton Bikes Model PL01
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V547000·2022-07-28

    Commercial trucks recalled for faulty steering gear assemblies

    PACCAR Incorporated is recalling certain 2022–2023 Peterbilt and Kenworth commercial trucks due to incorrectly assembled steering gears that may fracture. A fractured steering gear can cause loss of steering control, increasing crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 365, W990, 367, 389
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2022·2022-07-27

    Spinal fixation removal key fracture risk under misuse conditions

    The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2022·2022-07-27

    Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk

    Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2022·2022-07-13

    Ossur Variflex Suba Junior prosthetic foot may crack under impact

    Ossur has recalled 410 Variflex Suba Junior prosthetic feet due to cracking and breaking under impact stress. The device is designed for children and adolescents worldwide.

    Product
    OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2022·2022-04-27

    Acumed Cannulated Screws Recalled for Insufficient Axial Pullout Strength

    Acumed LLC is recalling Cannulated Screws (4.0mm x 12mm) that may not have sufficient strength to hold bone fragments together, risking fracture or joint damage.

    Product
    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
    Category
    Medical Device
    Distribution
    Distributed nationwide