The Recall Desk

Hazard

Surgical Injury recalls

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

What the numbers show

Total
90
Critical
0
Severe
45
Most recent
2024-03-20

Of the 90 surgical injury recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (50%) 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 surgical injury 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 90

  • HighFDA (Devices)·Z-0193-2018·2017-12-13

    Pro-Med Instruments Recalls DORO Sterile Disposable Skull Pins Due to Breakage

    Pro-Med Instruments is recalling DORO Sterile Disposable Skull Pins because two instances of pin tip breakage were reported during surgery.

    Product
    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Navigation Software Shift

    Zimmer Biomet is recalling 21 ROSA Surgical Devices because an undetected shift between the navigation software display and actual patient anatomy was identified.

    Product
    ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0040-2018·2017-10-25

    Genesys Binary Screwdriver Recalled Due to Threaded Shaft Breakage

    Genesys Orthopedics is recalling 120 Binary Screwdrivers because the threaded inner shaft tip can break off during cervical screw insertion.

    Product
    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adj
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-3202-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 150 nonsterile orthopedic drill bits because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3219-2017·2017-10-04

    Teleflex Percuvance Gripper Grasper Tool Tip Recall for Connection Issues

    Teleflex Medical is recalling 20,039 Percuvance Gripper Grasper Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

    Product
    Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-2617-2017·2017-06-28

    DePuy Mitek LATARJET Drill Tip Recall Due to Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Top Hat Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0891-2017·2016-12-28

    Amendia Recalls Optimus Fixed Awl Due to Tip Breakage During Surgery

    Amendia, Inc. is recalling nine Optimus Fixed Awl devices because the tip broke after impaction during surgery. The devices were distributed to Florida, Georgia, Illinois, Missouri, and Texas.

    Product
    Optimus Fixed Awl
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0765-2017·2016-12-21

    Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage

    Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or during use.

    Product
    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0325-2017·2016-11-09

    FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during surgery.

    Product
    Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2675-2016·2016-09-07

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.

    Product
    STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2677-2016·2016-09-07

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported shaft rotation interruptions and jaw opening failures.

    Product
    CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2387-2016·2016-08-17

    Integra External Fixation System Slotted Post Recall for Breakage During Use

    Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they broke during use at the surgical site.

    Product
    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2390-2016·2016-08-17

    Stryker Triathlon Tibial Alignment Handle Recalled Due to Weld Defect

    Stryker Howmedica Osteonics is recalling 47 units of the Specialty Triathlon Tibial Alignment Handle because the secondary locking mechanism may disassociate during surgery due to a weld defect.

    Product
    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2016·2016-04-20

    Intuitive Surgical Recalls da Vinci S Surgical System User Manuals

    Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using non-approved instruments with ablation probes may increase microscopic metallic particulates.

    Product
    da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments inclu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2016·2016-04-13

    MicroAire PAL-R4011XL Cannula Recalled Due to Breakage During Surgery

    MicroAire is recalling PAL-R4011XL cannulas because three reports indicated the devices bent or broke during surgical procedures.

    Product
    MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0821-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal 12 mm XL Stapler Handles

    Medtronic is recalling 327,797 Endo GIA Ultra Universal 12 mm XL Stapler Handles worldwide because the staplers may fail to fire or the articulating lever may disengage during surgery.

    Product
    Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0819-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Short Stapler Handles

    Medtronic is recalling 364,768 Endo GIA Ultra Universal Short Stapler Handles because they may fail to fire or partially fire, and the articulating lever may disengage during use.

    Product
    Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0820-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Stapler Handles Due to Firing Defects

    Medtronic is recalling 1,102,166 Endo GIA Ultra Universal Standard Stapler Handles worldwide because they may fail to fire or partially fire during surgery.

    Product
    Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0422-2016·2015-12-30

    Aesculap Flexible Screw Driver Recalled Due to Potential Shaft Breakage

    Aesculap, Inc. is recalling 37 Flexible Screw Driver SJ706R units because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

    Product
    Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2016·2015-12-16

    Zimmer Persona EM Proximal Tube Recalled for Ratchet Latching Failure

    Zimmer, Inc. is recalling 156 Persona EM Proximal Tubes because the ratchet teeth may not latch onto the rod.

    Product
    Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2823-2015·2015-10-07

    Medtronic Solera Screwdrivers Recalled for Tip Deformation Risk

    Medtronic Navigation is recalling 2,346 Solera screwdrivers used in spine surgery because specific conditions may cause the tips to deform or break.

    Product
    P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. The Medtronic Navig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2015·2015-09-30

    Brainlab Disposable Reflective Marker Spheres Recalled for Separation Risk

    Brainlab AG is recalling Disposable Reflective Marker Spheres because they may separate at the mid-point seal, posing a risk to patients during image-guided surgery.

    Product
    Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2015·2015-07-08

    New Star Lasers Recalls StoneLight 30 Laser Systems Due to Energy Discrepancy

    New Star Lasers is recalling 52 StoneLight 30 Laser Systems because a software issue may cause the delivered energy to differ from the displayed value.

    Product
    StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, a
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1128-2015·2015-02-25

    Mako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction

    Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application RIO because the surgical burr may continue spinning outside the intended boundary after controls are released.

    Product
    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide