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.

1501–1525 of 1694

  • HighFDA (Devices)·Z-0963-2013·2013-03-27

    DePuy Spine Recalls CONFIDENCE Spinal Cement System Kits

    DePuy Spine is recalling CONFIDENCE Spinal Cement System Kits because the cement mixer may not turn properly and could jam or get stuck during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2013·2013-03-27

    Allen Medical Systems Recalls Traction Boots Due to Assembly Defect

    Allen Medical Systems is recalling 24 traction boots because incorrect assembly could cause the boot to detach, allowing a patient's leg to fall during surgery.

    Product
    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0962-2013·2013-03-27

    DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk

    DePuy Spine is recalling CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus kits because the cement mixer may jam or fail to turn properly during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2013·2013-03-27

    DePuy Confidence Spinal Cement Mixer Recall for Jamming Defect

    DePuy Spine is recalling the Confidence Spinal Cement System 5cc Kit because the cement mixer may not turn properly and may jam or get stuck during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2013·2013-03-27

    DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk

    DePuy Spine is recalling 549 CONFIDENCE Spinal Cement System kits because the cement mixer may jam or fail to turn properly during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0945-2013·2013-03-20

    Philips CT Systems Recalled for Patient Table Brake Malfunction

    Philips is recalling 4,797 CT systems because a vertical brake malfunction caused an unexpected downward movement of the patient table.

    Product
    Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2013·2013-03-20

    GE Healthcare Recalls Cardiovascular X-ray Systems Due to Locking Nut Issue

    GE Healthcare is recalling specific cardiovascular X-ray imaging systems because a locking nut on the overhead video monitor suspension might loosen.

    Product
    GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2013·2013-03-20

    Medtronic O-arm Imaging System Recalled for Braking System Failure

    Medtronic is recalling 463 O-arm Imaging Systems worldwide due to a potential failure of the braking system controlling vertical gantry movement.

    Product
    Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2013·2013-03-20

    Stryker Howmedica Command Instrument Broach Handle Recalled for Fracture Risk

    Stryker Howmedica is recalling 48 Command Instrument Broach Handles used in hip surgery due to reports of handle fracture and component disassociation.

    Product
    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0942-2013·2013-03-20

    Synthes Titanium Midface Distractor Recalled Due to Fit Issues

    Synthes USA is recalling 596 Titanium Midface Distractors because oversized tabs may prevent footplates from fitting properly.

    Product
    Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0893-2013·2013-03-06

    Stryker XIA 3 Iliac Screwdriver Recalled Due to Unthreading Risk

    Stryker Spine is recalling 46 units of the XIA 3 Iliac Screwdriver because the outer shafts may unthread during surgical use.

    Product
    Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2013·2013-02-20

    Aesculap Miethke Shunt System Recalled Due to Deflector Movement Issue

    Aesculap, Inc. is recalling 11 units of the Miethke Shunt System because the deflector may not move freely on the ventricular catheter.

    Product
    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2013·2013-02-13

    Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage

    Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2013·2013-02-13

    Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk

    Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0751-2013·2013-02-06

    Greatbatch Medical Recalls 45 Degree Angle Drivers for Noisy Operation

    Greatbatch Medical is voluntarily recalling 913 Small Angled Driver 45 units worldwide due to reports of noisy or rough operation.

    Product
    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface betw
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0705-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screw Recall for Potential Separation

    DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·13V034000·2013-01-30

    Wilson Livestock Trailer Recall for Lift Deck Guide Failure

    Wilson Trailer Company is recalling 2007-2013 livestock trailers because plastic deck guides may fail, allowing the lift deck to shift and fall.

    Product
    WILSON — WILSON LIVESTOCK TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0659-2013·2013-01-16

    Zimmer Ardis Interbody System Inserter Recalled for Release Knob Issues

    Zimmer, Inc. is recalling 170 Ardis Interbody System Inserters because the release knob may be difficult to turn, potentially leaving the implant engaged in the patient.

    Product
    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the insert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2013·2013-01-16

    Maquet Cardiosave Intra-Aortic Balloon Pump Recall for Cord Failure Risk

    Maquet is recalling 29 Cardiosave Intra-Aortic Balloon Pumps because the coiled cord assembly may fail if mishandled.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0626-2013·2013-01-09

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 180 Plum A+ Hyperbaric Infusion Pumps because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of medication.

    Product
    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0625-2013·2013-01-09

    Hospira Recalls Plum A+3 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 28,599 Plum A+3 infusion pumps worldwide because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of IV medication.

    Product
    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0612-2013·2013-01-02

    Beckman Coulter Recalls Access Immunoassay Systems Due to Pulley Defects

    Beckman Coulter is recalling Access Immunoassay Systems because pulley drive components may break or disconnect, causing inadequate washing or mixing.

    Product
    Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0574-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.

    Product
    SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0577-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.

    Product
    SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
    Category
    Medical Device
    Distribution
    Distributed nationwide