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.

851–875 of 1694

  • HighFDA (Devices)·Z-0446-2018·2018-02-07

    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 have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2018·2018-01-24

    Philips Ingenuity Core CT Scanner Recall for Fastener Torque Verification

    Philips is recalling one Ingenuity Core CT scanner because certain fasteners cannot be confirmed to be torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0385-2018·2018-01-24

    Fujifilm Aspire HD Plus Mammography Machines Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.

    Product
    Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digita
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0389-2018·2018-01-24

    Philips Brilliance 64 CT Scanner Recalled for Fastener Torque Issues

    Philips is recalling one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.

    Product
    Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0335-2018·2018-01-24

    Hamilton Medical Recalls Intellicuff Standalone Devices Due to Motor Failure

    Hamilton Medical is recalling 176 Intellicuff Standalone devices because the motor may cease to function during use, potentially affecting endotracheal tube cuff pressure.

    Product
    Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0388-2018·2018-01-24

    Philips Brilliance iCT Recalled for Potential Fastener Torque Defect

    Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0391-2018·2018-01-24

    Philips Ingenuity Core 128 CT Scanner Recall for Fastener Torque Issues

    Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0386-2018·2018-01-24

    Fujifilm Aspire Cristalle Mammography Machine Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down unintentionally.

    Product
    ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for scree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0323-2018·2018-01-17

    CareFusion Alaris PCA Pump Recall Due to Syringe Plunger Gripper Failure

    CareFusion is recalling Alaris PCA Pumps because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2018·2018-01-17

    CareFusion Recalls Alaris Syringe Pumps Due to Plunger Gripper Failure

    CareFusion is recalling Alaris Syringe Pump Model 8110 units because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V051000·2018-01-12

    Forest River Recalls 2017-2018 Recreational Trailers Due to Power Tongue Jack Defect

    Forest River is recalling specific 2017-2018 recreational trailers because a cracked touch pad on the power tongue jack may allow water entry, causing the jack to operate unintentionally.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN XLR, FREEDOM EXPRESS, VIKING, ROCKWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2018·2018-01-10

    Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening

    Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.

    Product
    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2018·2017-12-27

    Zimmer Dental Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 30 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2018·2017-12-27

    Rezum System Recall Due to Potential Needle Bond Failure During Prostate Treatment

    NxThera is recalling 113 Rezum System units because the needle bond may fail during deployment, posing a risk of injury to patients.

    Product
    Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0246-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0198-2018·2017-12-13

    BD Phoenix AP Instrument Recalled for Potential Robot Arm Movement

    Becton Dickinson & Co. is recalling seven BD Phoenix AP instruments due to a potential for unexpected robot arm movement.

    Product
    BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0160-2018·2017-11-29

    FDA Recalls Zimmer Biomet ROSA Surgical Devices Due to Sensor Failure

    The FDA is recalling 31 Zimmer Biomet ROSA Surgical Devices because a force feedback sensor may fail, causing the operating arm to continue moving instead of stopping.

    Product
    ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0105-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling three ROSA Brain 3.0 neurosurgical devices due to insufficient washers in the telescopic arm that allow unwanted movement.

    Product
    ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0164-2018·2017-11-29

    Medline Transfer/Gait Belt Recall Due to Locking Mechanism Failure

    Medline Industries is recalling 1,428 Transfer/Gait Belts because the locking mechanism may fail to secure the strap, allowing it to slip through the buckle.

    Product
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray and Screws Due to Design Incompatibility

    Exactech, Inc. is recalling 640 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0163-2018·2017-11-29

    Medline Plastic Transfer Belts Recalled for Locking Mechanism Failure

    Medline Industries is recalling 1,428 plastic transfer belts because the locking mechanism may fail, allowing the strap to slip through the buckle.

    Product
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0096-2018·2017-11-22

    Zimmer Biomet ROSA Surgical Device Recalled for Potential Force Sensor Break

    Zimmer Biomet is recalling 21 ROSA Surgical Devices due to a possible break in the Force Sensor connector. The devices were distributed to facilities in Ohio, Michigan, and Texas.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17E070000·2017-11-21

    Mack Recalls Kidde Fire Extinguishers Sold as Truck Accessories

    Mack Trucks is recalling Kidde fire extinguishers sold as accessories for its trucks because they may clog, require excessive force to activate, or have nozzles that detach, increasing injury risk during a fire.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide