The Recall Desk

Hazard

Mechanical Failure recalls

1,694 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,694
Critical
7
Severe
304
Most recent
2026-09-02

Of the 1,694 mechanical failure recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 304 (18%) 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 mechanical failure 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.

1176–1200 of 1694

  • SevereFDA (Devices)·Z-1604-2015·2015-05-20

    HeartWare HVAD Pump Driveline Splice Kit Recalled for Failure Risk

    HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.

    Product
    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit sid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2015·2015-05-20

    Philips ADAC Vertex Gamma Cameras Recalled for Mechanical Drift Hazard

    Philips Medical Systems is recalling 918 ADAC Vertex Gamma Cameras because detector heads may drift and contact patients during imaging.

    Product
    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2015·2015-05-06

    Synthes Small Battery Drive Oscillating Saw Attachment Recall

    The Anspach Effort, Inc. is recalling Synthes Small Battery Drive Oscillating Saw Attachments because they may disengage during surgery, posing a risk of injury.

    Product
    Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1523-2015·2015-05-06

    Zimmer Anatomical Shoulder Handle Recalled Due to Attachment and Removal Difficulties

    Zimmer GmbH is recalling 30 units of Anatomical Shoulder Handles for Rasps due to high resistance during attachment and seizing during removal, which may delay surgery.

    Product
    Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1453-2015·2015-04-22

    US Endoscopy Recalls Talon Grasping Devices Due to Detached Wire Component

    US Endoscopy Group Inc is recalling 1,695 Talon Grasping Devices because a wire component on the distal grasping assembly became detached.

    Product
    Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1377-2015·2015-04-15

    Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent

    Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.

    Product
    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1394-2015·2015-04-15

    Toshiba INFX-8000V Interventional Angiography System Recall for Brake Defect

    Toshiba is recalling 28 INFX-8000V Interventional Angiography Systems because the table base rotational brake may not engage when force is applied to the table top.

    Product
    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2015·2015-04-15

    Carestream CS 8100 3D Dental X-Ray Devices Recalled for Unexpected Head Descent

    Carestream Health is recalling 470 CS 8100 3D dental X-ray units because the device head may descend unexpectedly, posing a risk of injury to patients or operators.

    Product
    CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic su
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1303-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide because a fault causes distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2015·2015-04-01

    Flower Orthopedics Recalls Variable Angle Locking Pegs Due to Failure

    Flower Orthopedics is recalling 901 Variable Angle Locking Pegs because they failed to lock during distal radius procedures, resulting in one scheduled revision surgery.

    Product
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1304-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2015·2015-03-25

    Stryker Recalls Triathlon Distal Capture Assembly Due to Weld Disassociation Risk

    Stryker Howmedica Osteonics is recalling 2,030 Triathlon Distal Capture Assemblies because a weld may disassociate, potentially causing the trigger mechanism to become loose or disassociated.

    Product
    Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2015·2015-03-18

    Synthes Inserter for Titanium Elastic Nails Recalled for Mechanical Failure

    Synthes, Inc. is recalling Inserter for Titanium Elastic Nails due to potential mechanical failures including shaft breakage and chuck malfunction.

    Product
    Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V139000·2015-03-11

    Mack Pinnacle Trucks Recall Fifth Wheel Latch Defect

    Mack is recalling 2012-2015 Pinnacle trucks because the fifth wheel latch switch may be pushed accidentally, causing the trailer to disconnect.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2015·2015-03-11

    Biosense Webster Recalls LASSO NAV Duo Loop eco Catheters

    Biosense Webster is recalling LASSO NAV Duo Loop eco Catheters due to reports of difficulty retracting and damage to the spine cover.

    Product
    LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1092-2015·2015-02-18

    Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks

    Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.

    Product
    MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1089-2015·2015-02-18

    Biomet Telluride Percutaneous Rod Inserter Long Recalled for Design Defect

    Biomet Spine is recalling 10 units of the Telluride Percutaneous Rod Inserter Long because the device lacks a locking feature, posing a risk of rod disengagement during surgery.

    Product
    Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1062-2015·2015-02-18

    Maquet Intra-Aortic Balloon Pump Demonstration Units Recalled for Ferrule Cap Defect

    Maquet Datascope is recalling specific intra-aortic balloon pump demonstration units because a ferrule cap was not removed, which could prevent connection or become dislodged in the device.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1084-2015·2015-02-18

    Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure

    Integra LifeSciences is recalling 1,053 Mayfield Ultra 360 Base Units because the locking handle mechanism may fail during use, posing a risk to patients.

    Product
    The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2015·2015-02-18

    Siemens Symbia S Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling 719 Symbia S series systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2015·2015-02-18

    Siemens Symbia T Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling Symbia T series imaging systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2015·2015-02-11

    Hospira Recalls Plum A+ Infusion Systems with Cracked Pole Clamp Assemblies

    Hospira Inc. is recalling 102 Plum A+ Infusion Systems because cracked pole clamp assemblies prevent the devices from securely attaching to IV poles.

    Product
    Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's ma
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1056-2015·2015-02-11

    Siemens ACUSON SC2000 Ultrasound System Control Panel Bolt Recall

    Siemens is recalling 230 ACUSON SC2000 ultrasound systems because a bolt holding the control panel may fail, preventing the panel from locking into position.

    Product
    ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdomin
    Category
    Medical Device
    Distribution
    0 states