The Recall Desk

Hazard

Device Failure recalls

240 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device 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.

101–125 of 240

  • HighFDA (Devices)·Z-2190-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.

    Product
    COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2024·2024-07-03

    Medtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect

    Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.

    Product
    MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect

    Medtronic is recalling eight COBALT XT VR MRI SureScan implantable cardioverter defibrillators due to weld cracks that caused device failure during manufacturing.

    Product
    COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2024·2024-07-03

    Medtronic Implantable Defibrillator Recalled Due to Manufacturing Weld Crack

    Medtronic is recalling 14 Cobalt XT HF CDT-D MRI SureScan implantable defibrillators due to a manufacturing weld defect that could cause device failure.

    Product
    Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2024·2024-06-12

    Vascular graft slider component may separate from core

    Atrium Medical's ADVANTA VXT vascular graft may experience separation of the slider mechanism from its core, affecting over 11,000 US units. No injuries have been reported.

    Product
    ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2024·2024-06-12

    Vascular graft device recalled due to swivel rod separation

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect could compromise device function.

    Product
    FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2024·2024-06-12

    Vascular Graft Component Separation Recall - Atrium Medical ADVANTA VXT

    Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft due to reported separation of the Swivel Rod from the Swivel Core. The component separation poses a risk of device failure.

    Product
    ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2024·2024-06-12

    Vascular graft recalled for slider rod component separation

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from its Swivel Core. The recall affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1964-2024·2024-06-12

    Vascular Graft Component Separation Recall from Atrium Medical

    Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts due to reports of Slider GDS Swivel Rod separation from the Swivel Core. Component separation could compromise device function.

    Product
    ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2024·2024-06-12

    Vascular Graft Component Separation Recall: ADVANTA VXT Slider

    Atrium Medical recalls ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. The defect affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2024·2024-06-12

    Vascular Graft Component Separation Risk Triggers Worldwide Device Recall

    Atrium Medical recalls FLIXENE vascular grafts due to reported separation of the Swivel Rod from the Swivel Core, creating gaps that could affect device function. Over 53,000 units worldwide are affected.

    Product
    FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2024·2024-06-12

    Vascular graft component separation in Atrium Medical ADVANTA VXT devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts worldwide due to reports of separation between the swivel rod and swivel core. The component failure could affect graft function.

    Product
    ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1678-2024·2024-05-22

    Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Failure

    Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment, which may prevent proper guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1683-2024·2024-05-22

    Boston Scientific cardiac catheters recalled for polyurethane delamination

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. Approximately 37,252 catheters in specific batches are affected worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1692-2024·2024-05-08

    Left ventricular assist system implant kit recalled for potential inflow cannula seal leak

    Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.

    Product
    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2024·2024-03-27

    Angiodynamics Guidewire Introducer Recall Due to Manufacturing Defect

    Angiodynamics recalls approximately 5,840 guidewire introducers with manufacturing defects that may prevent proper guidewire insertion during vascular procedures. The defect could cause procedural delays requiring equipment exchange.

    Product
    MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2024·2024-03-20

    D-Clip Surgical Applier Recalled for Failure to Release During Surgery

    FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.

    Product
    D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1166-2024·2024-03-06

    Medtronic Duet Catheter System Recalled for Potential Disconnection Risk

    Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1061-2024·2024-03-06

    AirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk

    Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2024·2024-03-06

    AirLife Adult Manual Resuscitator Kits Recalled for Component Failure

    Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1065-2024·2024-03-06

    AirLife Manual Resuscitator recalled for broken components causing ventilation failure

    Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1064-2024·2024-03-06

    AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation

    Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.

    Product
    AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure

    Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1058-2024·2024-03-06

    AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation

    Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2024·2024-03-06

    Colonoscope Model CF-H180AL Recalled Due to Missing Protective Adhesive

    Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.

    Product
    Colonoscope, Model Number CF-H180AL.
    Category
    Medical Device
    Distribution
    Distributed nationwide