The Recall Desk

Hazard

Mechanical Defect recalls

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

What the numbers show

Total
283
Critical
2
Severe
11
Most recent
2026-07-22

Of the 283 mechanical defect recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (4%) 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 mechanical defect 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.

151–175 of 283

  • HighFDA (Devices)·Z-0477-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because set screws and sleeves were found out of place during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper installation.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0442-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0497-2018·2018-02-07

    Smiths Medical Recalls Graseby 3300 Pumps Due to Key Mismatch

    Smiths Medical is recalling 77 Graseby 3300 syringe pumps and accessories because the supplied lock and key may not match the standard key.

    Product
    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0331-2018·2018-01-17

    Philips Brilliance iCT CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling 702 Brilliance iCT computed tomography systems because screws holding an internal gantry component may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3136-2017·2017-09-27

    Medtronic Euphora Balloon Catheter Recalled for Stylette Removal Difficulties

    Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 69,081 units distributed in the US and worldwide.

    Product
    Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2017·2017-07-05

    Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue

    Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.

    Product
    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2324-2017·2017-06-21

    Pentax Video Bronchoscopes Recalled for Loose Suction Arms

    Pentax of America Inc is recalling 1,701 video bronchoscopes due to loose suction arms. The action retrospectively documents corrections made in 2010-2011.

    Product
    Video Bronchoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2325-2017·2017-06-21

    Pentax Video Cytoscopes Recalled for Loose Suction Arms

    Pentax of America Inc. is recalling Video Cytoscopes to correct loose suction arms. This action retrospectively documents corrections made in 2010-2011.

    Product
    Video Cytoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2017·2017-06-07

    Zimmer Biomet Recalls AFFIXUS Hip Fracture Nail Due to Sizing Defect

    Zimmer Biomet is recalling 33,500 AFFIXUS Hip Fracture Nail units worldwide because certain undersized specifications may prevent the nail from properly engaging with the targeting jig.

    Product
    AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2017·2017-05-24

    Bausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System

    Bausch & Lomb is recalling specific lots of the SoftPort Easy-Load Lens Delivery System due to reports of kinked haptics during lens delivery.

    Product
    SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic pull
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2017·2017-05-10

    BD FlowSmart Set MiniMed Pro-set Recalled for Bent Catheters

    Becton Dickinson is recalling 57,750 units of BD FlowSmart Set MiniMed Pro-set in California due to reports of bent catheters causing high blood glucose.

    Product
    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1753-2017·2017-04-12

    Philips BrightView X Gamma Camera Recall Due to Brake Hub Assembly Error

    Philips Medical Systems is recalling 27 BrightView X gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, an
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1691-2017·2017-04-05

    Zimmer Biomet Recalls Altius M-INI OCT Spinal Fixation System

    Zimmer Biomet is recalling 141 units of the Altius M-INI OCT Posterior Spinal Fixation System because the driver cannot mate with the screw head tulip.

    Product
    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2017·2017-02-22

    Siemens Oncor Avant-garde Radiation Therapy Systems Recalled for Sensor Defects

    Siemens is recalling 194 Oncor Avant-garde radiation therapy systems due to incorrect collimator position displays and improper weld seams.

    Product
    ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0969-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to reports of sheath separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of sheath separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial
    Category
    Medical Device
    Distribution
    Distributed nationwide