The Recall Desk

Hazard

Mechanical Failure recalls

1,703 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,703
Critical
7
Severe
366
Most recent
2026-10-21

Of the 1,703 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 366 (21%) 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.

101–125 of 1703

  • HighFDA (Devices)·Z-2526-2024·2024-08-14

    Luminos dRF Max X-ray Display Support Arm May Unintentionally Lower

    Siemens recalled 24 units of the Luminos dRF Max X-ray display system because the support arm may unintentionally lower, potentially injuring personnel positioned beneath the equipment.

    Product
    Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2024·2024-07-17

    Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.

    Product
    RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2024·2024-07-17

    Blood Pump Rotor for Hemodialysis System Recalled for Loose Components

    Fresenius Medical Care is recalling Blood Pump Rotor components used in hemodialysis systems after reports of loose or dislodged guide sheaves during use. The defect affects 372 units distributed nationwide and in Canada.

    Product
    190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2024·2024-07-17

    Blood Pump Rotor Spare Part Recall Due to Loose Guide Sheaves

    Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.

    Product
    RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2024·2024-07-03

    Stryker Hoffman LRF Wire Tensioner Adjustment Ring May Become Loose

    Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.

    Product
    Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2024·2024-06-12

    Vascular Graft Device Recalled for Slider Component Separation

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider component from the swivel core. The recall affects 53,308 units worldwide.

    Product
    ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2024·2024-06-12

    FDA Recalls ADVANTA VXT Vascular Grafts Due to Component Separation

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts because the Slider GDS Swivel Rod may separate from the Swivel Core. A total of 53,308 units are affected.

    Product
    ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2024·2024-06-12

    Vascular graft slider component separation reported in ADVANTA VXT

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units affected worldwide.

    Product
    ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2024·2024-06-12

    Vascular graft component separation reported in FLIXENE Slider GDS devices

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation between the Slider GDS Swivel Rod and Swivel Core, affecting 53,308 units distributed worldwide.

    Product
    FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2024·2024-06-12

    Vascular graft separation issue prompts FDA recall of Atrium Medical ADVANTA VXT units

    Atrium Medical Corporation is recalling its ADVANTA VXT vascular grafts due to complaints of swivel rod separation from the swivel core, which could affect device function and patient safety.

    Product
    ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1957-2024·2024-06-12

    Vascular graft recalled due to slider component separation risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider GDS swivel rod separating from the swivel core. Approximately 53,308 units are affected worldwide.

    Product
    ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2024·2024-06-12

    Atrium Medical Vascular Graft Swivel Component Separation Recall

    Atrium Medical recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the swivel rod from the swivel core. The affected units were distributed throughout the United States and to 60 additional countries.

    Product
    ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2024·2024-06-12

    ADVANTA VXT Vascular Graft Recalled for Slider Rod Separation

    The ADVANTA VXT vascular graft is being recalled because its slider rod can separate from the swivel core, creating a gap between components. No injuries have been reported.

    Product
    ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2024·2024-06-12

    Vascular graft recalled due to swivel rod separation risk

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. The recall affects 53,308 units distributed worldwide.

    Product
    FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2024·2024-06-12

    FLIXENE Vascular Graft Recall Due to Swivel Rod Component Separation

    Atrium Medical recalls FLIXENE vascular grafts due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core. Component separation in implanted vascular grafts could compromise device function.

    Product
    FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2024·2024-05-29

    CT Scanner Component Fracture Risk in Incisive System

    Philips Incisive CT scanner systems may have a defective metal mounting box that could fracture and expel fragments during operation. Eighteen units are affected nationwide.

    Product
    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2024·2024-05-29

    2008T BlueStar Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component

    Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component

    Fresenius recalls 931 BlueStar hemodialysis machines due to loose guide sheaves in blood pump rotors. Facilities should immediately discontinue use of affected units.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Guide Sheave Failure Recall

    Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2024·2024-03-06

    Rebstock Holding Rod for Fixation May Move Uncontrollably

    The Rebstock Holding rod for fixation, a surgical instrument, may move or twist uncontrollably during use, potentially compromising patient safety if the movement transfers to attached equipment.

    Product
    Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·24V141000·2024-02-23

    Mercedes-Benz Tourrider Recalled for Wheelchair Lift Barrier Defect

    Daimler Coaches is recalling 2022-2024 Mercedes-Benz Tourrider vehicles equipped with BraunAbility wheelchair lifts because the outer barrier may deploy unexpectedly.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ TOURRIDER BUSINESS, TOURRIDER PREMIUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2024·2024-02-21

    Captus 4000e Thyroid Uptake Systems spring failure poses fall risk

    Mirion Technologies recalls 467 Captus 4000e Thyroid Uptake Systems due to spring arm failure that can cause the collimator to fall, posing potential injury risk to patients and operators.

    Product
    Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2024·2024-02-07

    Knee replacement implant recall due to material oxidation risk

    Howmedica Osteonics is recalling knee replacement implants manufactured with aged UHMWPE raw material that may have elevated oxidation levels, which could degrade the material's mechanical properties.

    Product
    LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2024·2024-02-07

    NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail

    A ball stud on the gas strut may fail on NovoTHOR Whole Body Light Pod units, potentially causing injury if the canopy malfunctions while someone is using the device.

    Product
    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
    Category
    Medical Device
    Distribution
    17 states