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.

201–225 of 240

  • HighFDA (Devices)·Z-0325-2022·2021-12-08

    Hurricane RX Dilation Balloon Recalled Due to Pinhole Defect Causing Pressure Loss

    Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2022·2021-12-08

    Boston Scientific HURRICANE RX Dilation Balloon Pressure Loss Recalled

    Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.

    Product
    HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2022·2021-12-01

    Medical Imaging System May Fail to Release X-rays Under Specific Conditions

    Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.

    Product
    Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0234-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk

    Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2022·2021-11-24

    Cordis SMART FLEX Biliary Stent System recalled for potential tip separation

    Cordis is recalling the SMART FLEX 6x150 BIL biliary stent system due to potential separation of the distal tip. Approximately 26 units were distributed in the U.S. and Canada. Affected patients should contact their healthcare provider.

    Product
    SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0217-2022·2021-11-24

    SMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement

    Cordis Corporation is recalling 3 units of SMART FLEX 6x120 BIL biliary stents due to a potential for distal tip dislodgement or separation. No illnesses or injuries have been reported.

    Product
    SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2512-2021·2021-09-29

    Univation X Knee Implant Devices Recalled Due to Loosening Risk

    Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2021·2021-09-29

    Univation X Knee Implant Devices Recalled for Risk of Loosening

    Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could require revision surgery.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2403-2021·2021-09-15

    EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk

    Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.

    Product
    EV3 Pipeline Flex Embolization Device with Flex Shield Technology
    Category
    Medical Device
    Distribution
    48 states
  • CriticalFDA (Devices)·Z-2197-2021·2021-08-18

    Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures

    Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.

    Product
    HeartWare HVAD Pump Accessories, REF MCS1753AK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2193-2021·2021-08-18

    HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns

    Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2192-2021·2021-08-18

    HeartWare HVAD System Recalled Due to Higher Mortality Rates

    Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2194-2021·2021-08-18

    HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF 1104JP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2021·2021-08-18

    Biomet Hip Implant System Recalled Due to Potential Fretting Corrosion

    Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2021·2021-08-18

    Hip Implant Component Failure Risk From Inner Taper Fretting Corrosion

    Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2021·2021-08-18

    Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk

    Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2021·2021-08-18

    Arcos Hip System Cones Recalled for Potential Inner Taper Corrosion

    Biomet recalled 11 Arcos Modular Revision Hip System proximal cones due to potential inner taper fretting corrosion and device failure that could require surgical intervention. Affected units distributed nationwide.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2021·2021-08-18

    Biomet Arcos Hip Prosthesis Recalled Due to Device Failure Risk

    Biomet is recalling certain Arcos Modular Revision Hip System components due to risk of device failure and fretting corrosion. Affected patients may require revision surgery.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2021·2021-08-18

    Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk

    Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2021·2021-08-18

    Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator

    Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.

    Product
    MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2021·2021-08-18

    Hip implant component recalled due to potential corrosion and failure risk

    Biomet is recalling 11 units of a hip replacement component that could experience inner taper corrosion and failure, potentially requiring surgical intervention. No injuries have been reported.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2021·2021-08-18

    Hip Replacement Component Recalled for Potential Device Failure Risk

    Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2264-2021·2021-08-18

    Hip Implant Component Recalled for Fretting Corrosion Risk

    Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion that could lead to device failure and require surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2021·2021-08-18

    Biomet Arcos Hip Implant Component Recalled for Potential Fretting Corrosion

    Biomet is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body components due to potential fretting corrosion at the inner taper joint that could cause device failure and require revision surgery.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
    Category
    Medical Device
    Distribution
    Distributed nationwide