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.

51–75 of 1694

  • HighFDA (Devices)·Z-0898-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Recalled for Detector Fall Risk

    GE Healthcare's Infinia nuclear medicine systems may have been transported without proper detector support, risking detector falls and life-threatening injury. The recall affects 93 units worldwide.

    Product
    GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0863-2025·2025-01-22

    8MM Dual Blade Retractors recalled for frayed or broken grip cables

    Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. and internationally.

    Product
    8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0900-2025·2025-01-22

    GE Healthcare nuclear medicine imaging systems recalled for detector fall risk

    GE Healthcare is recalling 30 units of certain nuclear medicine imaging systems distributed worldwide. If transported without proper detector support, the systems risk detector mounting failure and life-threatening injury.

    Product
    GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0859-2025·2025-01-22

    Intuitive Surgical Recalls Fenestrated Bipolar Forceps Over Frayed Grip Cables

    Intuitive Surgical recalls 8MM Fenestrated Bipolar Forceps due to increased complaints about frayed or broken grip cables on 12,340 units distributed nationwide and internationally.

    Product
    8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0883-2025·2025-01-22

    Intuitive Surgical recalls 8MM Force Bipolar surgical instruments due to grip cable failures

    Intuitive Surgical is recalling approximately 46,759 8MM Force Bipolar IS4000 surgical instruments nationwide and internationally due to reports of frayed or broken grip cables that could compromise instrument function during surgical use.

    Product
    8MM,FORCE BIPOLAR,IS4000 REF 471405
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0862-2025·2025-01-22

    Surgical Retractor Grip Cables May Fray or Break During Use

    Intuitive Surgical is recalling 738 units of the 8MM Atrial Retractor (Model 470246) due to reports of frayed or broken grip cables on reusable instruments. The defect could compromise instrument performance during surgical procedures.

    Product
    8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0893-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Detector Fall Risk

    GE Healthcare has recalled certain nuclear medicine systems that could have detectors fall during improper transport, risking life-threatening injury. The recall affects 283 units worldwide.

    Product
    GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0962-2025·2025-01-22

    Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk

    Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.

    Product
    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E005000·2025-01-17

    Timken Recalls Wheel Hub Bearings Due to Oil Leak Risk

    Timken is recalling specific wheel hub bearings sold by December 31, 2024, because an incorrect oil plug thread may cause oil leaks and bearing failure.

    Product
    WHEELS:HUB recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2025·2025-01-15

    Mobile Radiographic System Arm May Drop Due to Missing Safety Bolts

    GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.

    Product
    GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0813-2025·2025-01-15

    Medical radiographic system arm drop hazard due to missing safety bolts

    GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

    Product
    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0668-2025·2024-12-25

    FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure

    Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.

    Product
    Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0654-2025·2024-12-25

    Kirwan Surgical Disposable Bipolar Pencils recalled for potential tube failure

    Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.

    Product
    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0667-2025·2024-12-25

    Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall

    Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·25070·2024-12-19

    Melii Baby Silicone Spoons Recalled for Choking Hazard

    Melii Baby silicone spoons for babies can break apart during use, creating a choking hazard. About 85,100 units sold through multiple retailers from April to August 2024 are affected; consumers should stop using them immediately.

    Product
    Silicone spoons for babies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2025·2024-12-18

    ReNew Microscissor Tip Disposable Recalled Due to Heat Shrink Failure

    Microline Surgical is recalling ReNew Microscissor Tip (Disposable) lot 00172110 due to a 2% failure rate where the heat shrink breaks off.

    Product
    Microscissor Tip (Disposable); Microline Catalog #: 3122.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2025·2024-12-18

    Philips Allura Xper X-ray Systems Prone to Clamping Bolt Failure and Collision Risk

    Philips Allura Xper radiological systems may experience propeller motor and x-ray tube locking bolt breaks, causing erratic C-arm movements with potential for collision with patients or bystanders, and unnecessary radiation exposure.

    Product
    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2025·2024-12-11

    Mobile C-arm hand switch defect may cause unintended X-ray emission

    Ziehm Solo Digital Mobile C-arm devices may have hand switch defects that can cause unintended radiation emission when exposed to impacts or drops. The recalled units have been distributed in the U.S. and Puerto Rico.

    Product
    Ziehm Solo. Digital Mobile C-arm
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0578-2025·2024-12-11

    Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation

    Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.

    Product
    Ziehm Vision RFD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0575-2025·2024-12-11

    X-ray system hand switch may fail, risking unintended radiation exposure

    Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.

    Product
    Ziehm Vision system, x-ray, tomography, computed.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0521-2025·2024-12-04

    Surgical forceps and scissors handles recalled due to pin detachment

    MicroSurgical Technology is recalling MST Duet Reusable Handles for surgical forceps and scissors due to pin detachment risk. Six units distributed in the US; 18 internationally.

    Product
    Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable han
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0565-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set: Female Connector Separation Risk

    Baxter Healthcare recalls 8,394 MiniCap Extended Life PD Transfer Sets due to complaints of female connector separation from the transfer set body. This mechanical failure could interrupt dialysis treatment.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0568-2025·2024-12-04

    Baxter Dialysis Transfer Set Recalled for Connector Separation

    Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set (Part Number T5C4325K) due to increased complaints about the female connector separating from the main body of the device.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0304-2025·2024-11-20

    Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure

    Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide