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.

376–400 of 1694

  • HighFDA (Devices)·Z-1343-2020·2020-03-04

    Hologic Selenia Dimensions Mammography System Recalled for C-Arm Defects

    Hologic is recalling 72 Selenia Dimensions Mammography Systems because the C-arm may seize or drop during repairs and cleaning.

    Product
    Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1142-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1144-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recalled for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1340-2020·2020-02-26

    Siemens ARTIS Pheno-Interventional Fluoroscopic X-Ray System Recalled for Robotic Stand Defect

    Siemens Medical Solutions is recalling 96 ARTIS Pheno-Interventional Fluoroscopic X-Ray Systems because safety brakes may block the robotic stand, preventing intended movements.

    Product
    ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1111-2020·2020-02-19

    Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure

    Terumo is recalling 11 Advanced Perfusion Assembly Pump Guts units because pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualifi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1108-2020·2020-02-19

    Terumo Advanced Perfusion System 1 Roller Pump Recall for Shaft Failure

    Terumo is recalling 33 Advanced Perfusion System 1 Roller Pumps because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a quali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 87 Omega 4.75 mm PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1110-2020·2020-02-19

    Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure

    Terumo is recalling 16 Advanced Perfusion Assembly Pump Guts units because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical prof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0957-2020·2020-02-19

    Medtronic MiniMed 620G Insulin Pump Recall for Loose Reservoirs

    Medtronic is recalling MiniMed 620G insulin pumps not distributed in the US due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1109-2020·2020-02-19

    Terumo Advanced Perfusion System 1 Roller Pump Recall for Shaft Failure

    Terumo is recalling 106 Advanced Perfusion System 1 Roller Pumps because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a quali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2020·2020-02-05

    Mindray ABS800 Chemistry Analyzer Gas Spring Recall

    Mindray is recalling six ABS800 Chemistry Analyzers due to a potential gas spring failure that poses a low risk of impact injury to users.

    Product
    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0919-2020·2020-02-05

    Arthrex Fibulock Fibular Nail Instrument Set Recalled for Potential Blockage

    Arthrex, Inc. is recalling 47 units of the Fibulock Fibular Nail Instrument Set due to a potential for blockage of the Hub Attachment Tube.

    Product
    Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2020·2020-01-29

    Medicrea Pass LP Trocar K-wire Recalled for Fit Issues

    Medicrea International is recalling 30 units of Pass LP Trocar K-wires because they may not fit into conical cannulated screws.

    Product
    Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0799-2020·2020-01-22

    Trilliant Gridlock Ankle Screw Driver Bit Recalled for Specification Defect

    Trilliant Surgical is recalling 20 Gridlock Ankle Screw Driver Bits because they are out of specification and may fail to retain screws during implant procedures.

    Product
    Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and separate, posing a risk of entering the patient's oral cavity.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2020·2020-01-22

    Siemens ARTIS pheno X-Ray System Recalled for Potential Collision Sensor Blockage

    Siemens is recalling six ARTIS pheno X-ray systems because a collision sensor may falsely activate, permanently blocking system movement.

    Product
    Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2020·2020-01-15

    Stryker Pin To Rod Coupling Recalled for Clamping Failure

    Stryker is recalling Pin To Rod Couplings for the Hoffmann II Compact External Fixation System because they may fail to clamp the pin and rod as intended.

    Product
    Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Un
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2020·2020-01-08

    Medtronic Recalls O-arm O2 Imaging Systems Due to Belt Loosening

    Medtronic is recalling 90 O-arm O2 Imaging Systems because a manufacturing issue may cause the gantry tractor motor drive belt to loosen, potentially rotating 3D images relative to the patient's physical position.

    Product
    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0772-2020·2020-01-08

    Nucletron Flexitron Brachytherapy Afterloader Recalled for Cable Guide Failure

    Nucletron BV is recalling 383 Flexitron brachytherapy afterloader systems due to a component failure that may cause treatment interruption or incorrect source positioning.

    Product
    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This is
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0763-2020·2020-01-08

    Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Chain Failure

    Villa Sistemi Medicali is recalling 46 Juno DRF x-ray systems because the angulation chain may fail early due to metal fatigue.

    Product
    Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo X-ray Tables Due to Chain Failure Risk

    Villa Sistemi Medicali is recalling three Apollo X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0765-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo DRF X-ray Tables Due to Chain Failure

    Villa Sistemi Medicali is recalling seven Apollo DRF X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo EZ X-Ray Table Due to Chain Failure

    Villa Sistemi Medicali is recalling one Apollo EZ X-ray table because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motori
    Category
    Medical Device
    Distribution
    Distributed nationwide