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.

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 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.

526–550 of 1694

  • ModerateFDA (Devices)·Z-0599-2019·2018-12-19

    Tosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage

    Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to system errors and delays in patient test results.

    Product
    AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0463-2019·2018-12-12

    GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards

    GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.

    Product
    GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2019·2018-12-12

    Stephanix D2RS Digital Dynamic Remote System Recalled for Table Movement Risk

    Stephanix is recalling 17 D2RS Digital Dynamic Remote Systems because the table may continue moving after a command is released.

    Product
    STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional proc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2019·2018-12-12

    Capintec Recalls Captus 700 Thyroid Uptake Systems Due to Spring Arm Failure

    Capintec Inc is recalling 65 Captus 700 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.

    Product
    Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2019·2018-12-12

    Capintec Recalls Captus 3000 Thyroid Uptake Systems Due to Spring Arm Failure

    Capintec Inc is recalling 385 Captus 3000 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.

    Product
    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2019·2018-12-05

    Tosoh AIA-900 Analyzer Recalled for Potential Drive Motor Failure

    Tosoh Bioscience is recalling 247 AIA-900 Automated Immunoassay Analyzers due to a potential drive motor defect that may cause the device to stop functioning and delay patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V857000·2018-12-03

    Gulf Stream Vintage Cruiser Recalled for Insufficient Bearing Grease

    Gulf Stream is recalling 2019 Vintage Cruiser recreational trailers because inner hub bearings may lack sufficient grease, risking overheating and hub failure.

    Product
    GULF STREAM — GULF STREAM VINTAGE CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E111000·2018-12-01

    Luxfer Recalls One-Turn Valves Due to Potential Stem Ejection Risk

    Luxfer Canada Ltd. is recalling One-Turn Valves (part number MPVE-250) because the valve stem may forcibly eject if the knob is turned more than one turn, posing injury and fire risks.

    Product
    FUEL SYSTEM, OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0448-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Malfunction

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0450-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2019·2018-11-14

    Accuray Recalls CyberKnife M6 Systems Due to Wrist Component Failure Risk

    Accuray is recalling 93 CyberKnife M6 systems worldwide due to manufacturing variations in the robot wrist that may cause premature component failure.

    Product
    CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·18E100000·2018-11-07

    Dexter Trailer Axle Recall for Insufficient Bearing Grease

    Dexter Axle Company is recalling specific trailer axles because inner hub bearings may lack sufficient grease, risking overheating and failure.

    Product
    POWER TRAIN:AXLE HUBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0297-2019·2018-11-07

    Siemens Multix Fusion Radiographic Systems Recalled for Lifting Column Cable Defect

    Siemens is recalling 35 Multix Fusion radiographic systems because steel cables in the lifting column may rupture without triggering the safety lock, causing the arm to drop unexpectedly.

    Product
    Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digita
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0298-2019·2018-11-07

    Siemens AXIOM Multix MT Patient Table Recalled for Cable Failure Risk

    Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.

    Product
    AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0299-2019·2018-11-07

    Siemens Ysio Radiographic Systems Recalled for Potential Tube Arm Drop

    Siemens is recalling 142 Ysio radiographic systems because steel cables may rupture, causing the tube arm to drop unexpectedly during patient positioning.

    Product
    Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0300-2019·2018-11-07

    Siemens Ysio MAX Radiographic Systems Recalled for Cable Failure Risk

    Siemens is recalling 31 Ysio MAX radiographic systems because steel cables in the lifting column may rupture, causing the arm to drop unexpectedly.

    Product
    Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0207-2019·2018-10-31

    Howmedica Recalls Tritanium TL Steerable Inserter Due to Locking Mechanism Failure

    Howmedica Osteonics Corp. is recalling 58 units of the Tritanium TL Steerable Inserter because the locking mechanism may fail to function as intended due to lack of lubrication.

    Product
    Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter
    Category
    Medical Device
    Distribution
    Distributed nationwide