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.

1–25 of 283

  • HighFDA (Devices)·Z-2728-2026·2026-07-22

    Mobile Digital Radiographic System Arm Drop Risk During Patient Exams

    GE HealthCare is recalling certain Optima XR200/220/240amx Mobile Digital Radiographic Systems due to potential failure of the Column Safety mechanism, which could cause the X-ray arm to drop during patient exams. The issue stems from incomplete functional testing of the safety pawl after column replacement.

    Product
    Optima XR240amx, Mobile Digital Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2025·2025-09-03

    Surgical driver systems recalled over out of the box driver wobble

    IPC Powerease System units, REF 2300000, are recalled because of out of the box wobble of the driver. 214 units are affected.

    Product
    IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE S
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1326-2025·2025-03-19

    Beckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1254-2025·2025-03-12

    Baxter Spectrum IQ Infusion System may have missing motor mounting screws

    Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2025·2025-02-12

    VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect

    LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.

    Product
    SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1037-2025·2025-02-05

    HOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk

    Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2025·2025-01-22

    Intuitive Surgical Clip Applier Instruments Recalled for Frayed or Broken Cables

    Intuitive Surgical has recalled approximately 30,316 units of its 8MM Medium-Large Clip Applier instruments (Model 470327) due to reports of frayed or broken grip cables on the reusable surgical tools.

    Product
    8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0866-2025·2025-01-22

    Surgical Retractor Instruments Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.

    Product
    8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0856-2025·2025-01-22

    8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables

    Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0838-2025·2025-01-22

    NOA Medical Industries Hospital Bed Side Rails Recalled for Defective Engagement Button

    NOA Medical Industries is recalling 34 hospital bed side rails (Model 1055050GRY-BOX) because the red button used to engage the rails can break or become stuck, making it difficult to engage the safety rails.

    Product
    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0873-2025·2025-01-22

    Intuitive Surgical 8mm Cadiere Forceps Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 56,580 units of the 8mm Cadiere Forceps (Model 471049) due to increased complaints of frayed or broken grip cables on the reusable surgical instrument.

    Product
    8MM,CADIERE FORCEPS,IS4000 REF 471049
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0812-2025·2025-01-15

    GE Optima XR Mobile Radiographic System Column Safety Mechanism Defect

    GE Healthcare Optima XR mobile X-ray systems with column replacements may have missing bolts in the Column Safety mechanism. If bolts are missing and the internal cable fails, the arm could drop, creating a risk of injury to staff or patients.

    Product
    GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0802-2025·2025-01-15

    VACUETTE SAFELINK Blood Collection Holder May Leak Due to Defective Sleeve

    Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.

    Product
    VACUETTE SAFELINK, REF: 450210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2025·2024-11-13

    Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring

    Smith & Nephew is recalling 21 units of a Tandem Bipolar Hip System component due to an oversized retainer ring in the femoral head assembly. The affected devices were distributed internationally to nine countries.

    Product
    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3200-2024·2024-10-02

    MRI Scanner Loose Screws May Block Tabletop and Delay Diagnosis

    The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.

    Product
    Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 78213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening

    Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for Altered Component Spacing

    Maquet Cardiovascular is recalling 600 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System due to reports of C-Ring wire straightening and altered spacing between components. No adverse events have been reported.

    Product
    The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2024·2024-07-03

    Sonic Scaler Tip Holder May Be Oversized, Preventing Proper Seating

    The tip holder portion of Titan Blis-Sonic Scaler tips may be oversized, preventing proper seating in the scaler handpiece. This defect could result in the tip becoming loose during use.

    Product
    Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2024·2024-06-12

    Vascular graft separation defect recalled by Atrium Medical

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of internal components. The defect affects over 53,000 units distributed worldwide.

    Product
    ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2024·2024-06-12

    Vascular graft component separation reported in ADVANTA VXT devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. No injuries have been reported.

    Product
    ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2024·2024-06-12

    ADVANTA VXT Vascular Graft Slider Rod Separation Recall

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from the swivel core, with a gap between components. Approximately 53,308 units are affected globally.

    Product
    ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2024·2024-06-12

    Medline Sterile Iris Scissors Recall Due to Detachable Tip Protector

    Medline is recalling 67,811 units of sterile iris scissors because the tip protector may detach during use. The recall affects units distributed nationwide and internationally.

    Product
    MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2024·2024-06-12

    Vascular graft component separation: Atrium Medical ADVANTA VXT recall

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.

    Product
    ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2024·2024-06-12

    Vascular Graft Slider Component May Separate from Core

    Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide after reports of the slider swivel rod separating from the swivel core with a notable gap between components.

    Product
    ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24259·2024-06-06

    Wild Country Ropeman 1 Ascenders Recalled for Failure to Engage

    Salewa USA recalls Wild Country Ropeman 1 ascenders because the teeth can fail to engage, making it difficult or impossible to ascend. About 7,700 units sold in the United States since December 2022.

    Product
    Wild Country Ropeman 1 ascenders
    Category
    Consumer Product
    Distribution
    Distributed nationwide