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.

101–125 of 283

  • ModerateFDA (Devices)·Z-1372-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips for Fit Issues

    Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.

    Product
    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1390-2019·2019-05-29

    Thommen Medical Recalls Dental Adapters for Handpiece Due to Deformation Risk

    Thommen Medical AG is recalling 15 units of dental adapters for handpieces because the coupling may deform, making removal difficult.

    Product
    Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and scre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1264-2019·2019-05-08

    GE Healthcare Recalls 16 NM/CT 870 CZT Systems for Screw Issue

    GE Healthcare is recalling 16 NM/CT 870 CZT systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine syste
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1258-2019·2019-05-08

    GE Healthcare Recalls Discovery NM/CT 670 CZT Systems for Mounting Defect

    GE Healthcare is recalling three Discovery NM/CT 670 CZT systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.

    Product
    Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medici
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0986-2019·2019-04-03

    Maquet Cardiohelp Emergency Drive Recalled for Gearwheel Assembly Defect

    Maquet Cardiovascular is recalling 10 units of the Cardiohelp Emergency Drive because the gearwheel may have been incorrectly reassembled, leading to inadequate operation.

    Product
    Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0789-2019·2019-02-06

    Abbott Recalls Alinity i Processing Modules Due to Gear Pump Assembly Issue

    Abbott is recalling Alinity i Processing Modules because a gear pump assembly issue causes foaming and dried residue in the wash buffer reservoir.

    Product
    Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and auto
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0727-2019·2019-01-23

    Volcano Visions PV .035 Digital IVUS Catheter Recalled for Guidewire Issue

    Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.

    Product
    Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cyli
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0646-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 100 Tables Due to Roll Drift

    Deerfield Imaging is recalling 27 IMRIS ORT 100 tables because they may drift in the roll position during use, posing a risk of patient injury.

    Product
    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0647-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift

    Deerfield Imaging is recalling 14 IMRIS ORT 200 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS T2X Tables Due to Roll Position Drift

    Deerfield Imaging is recalling 15 IMRIS T2X tables because they may drift in the roll position while in use.

    Product
    IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0659-2019·2018-12-26

    Konica Minolta Recalls 151 X-Ray Systems Due to Unintentional Movement

    Konica Minolta is recalling 151 Advanced Universal U-Arm 4000 X-ray systems because the U-Arm may move unintentionally.

    Product
    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 300 Operating Room Tables

    Deerfield Imaging is recalling 14 IMRIS ORT 300 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V726000·2018-10-15

    Keystone Recalls 2019 Crossroads Fifth Wheels Due to Awning Switch Defect

    Keystone is recalling 2019 Crossroads Cruiser and Volante fifth wheels because defective awning switches may allow the awning to unroll while the vehicle is moving.

    Product
    CROSSROADS — CROSSROADS VOLANTE, CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3262-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues

    Biomet UK Ltd. is recalling 10 units of HipLOC Hip Fracture Fixation System plates due to an undersized bore that prevents the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3012-2018·2018-09-26

    Ventana Recalls CINtec p16 Histology Reagent Due to Dispenser Defects

    Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.

    Product
    CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3006-2018·2018-09-26

    Ventana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3002-2018·2018-09-26

    Ventana iVIEW Blue Plus Detection Kit Recalled for Dispenser Leaks

    Ventana Medical Systems is recalling iVIEW Blue Plus Detection Kits because leaking dispensers may cause false negative IHC results.

    Product
    ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3007-2018·2018-09-26

    Ventana CONFIRM anti-Estrogen Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Estrogen Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3013-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking CINtec p16 Histology Reagent Dispensers

    Ventana Medical Systems is recalling 240 units of CINtec p16 Histology reagent dispensers due to leaking and sticking issues that may cause false negative test results.

    Product
    CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2997-2018·2018-09-26

    Ventana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects

    Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3015-2018·2018-09-26

    Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3014-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking HPV III Probe Dispensers

    Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test results.

    Product
    INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3004-2018·2018-09-26

    Ventana ultraView Universal Alkaline Phosphatase Red Detection Kit Recalled

    Ventana Medical Systems is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3009-2018·2018-09-26

    Ventana Basal Cell IHC Reagent Recall Due to Dispenser Defects

    Ventana Medical Systems is recalling 75 units of Basal Cell IHC reagents due to leaking and sticking dispensers that may cause false negative results.

    Product
    VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states