The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 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.

351–375 of 881

  • HighFDA (Devices)·Z-1948-2020·2020-05-20

    Cardiac Assist Recalls TandemHeart Pump Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling 10 TandemHeart Pump Kits because an assembly error may prevent the device from priming.

    Product
    TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2020·2020-05-20

    Cardiac Assist Recalls TandemHeart Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling five TandemHeart pump kits because an assembly error may prevent the device from priming.

    Product
    TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2020·2020-05-13

    Delfi VariFit Contour Cuffs Recalled for Inadequate Weld

    Delfi Medical Innovations is recalling 59 units of VariFit Contour Cuffs due to a manufacturing defect that may cause the cuff to leak.

    Product
    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1846-2020·2020-05-13

    Applied Medical Recalls Python Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Python Embolectomy Catheters because the tips may separate during use, posing a risk of unintended dislodgement in patients.

    Product
    Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2020·2020-05-06

    Capso Vision Recalls CapsoCAM Plus Capsule Endoscopy Systems

    Capso Vision is recalling 1,882 CapsoCAM Plus capsule endoscopy systems because a defect in the capsule window may cause the housing to crack and leak during use.

    Product
    CapsoCAM Plus, UDI: 00867770000209
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1798-2020·2020-05-06

    Boston Scientific Recalls MoXy Laser Fiber for Breakage Risk

    Boston Scientific is recalling MoXy Laser Fibers to update instructions and reduce the likelihood of metal cap and fiber tip breakage.

    Product
    MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1499-2020·2020-03-25

    Philips Recalls HeartStart MRx Defibrillators Due to Internal Damage Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.

    Product
    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2020·2020-03-18

    Medicrea Recalls Pedicle Screws Due to Incorrect Component Orientation

    Medicrea International is recalling 3,529 pedicle screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the screw shank.

    Product
    Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2020·2020-03-18

    Cordis Recalls POWERFLEX P3 Catheters Due to Potential Seal Voids

    Cordis is recalling one lot of POWERFLEX P3 PTA Dilation Catheters due to potential voids in the proximal seal area.

    Product
    Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1432-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.

    Product
    Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1431-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Sterility and Function Defects

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1433-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1403-2020·2020-03-04

    MicroVention HydroFrame 18 Embolic System Recalled for Missing Implant Coil

    MicroVention is recalling 32 units of HydroFrame 18 embolic systems because the implant coil may be missing. The devices were distributed internationally.

    Product
    MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlu
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1405-2020·2020-03-04

    MicroVention HydroSoft Embolization Coils Recalled for Missing Implant Coils

    MicroVention is recalling 847 HydroSoft embolization coils because the implant coil may be missing from the packaging. The devices were distributed to 43 countries outside the United States.

    Product
    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1193-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1223-2020·2020-02-19

    Microvention AZUR Peripheral Coil System Recall for Missing Implant Coil

    Microvention is recalling 392 units of AZUR Peripheral Coil Systems because the implant coil may be missing from the devices.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 4
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1201-2020·2020-02-19

    Arrow FlexTip Plus Epidural Catheterization Set Recalled for Syringe Failures

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1203-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1175-2020·2020-02-19

    Arrow International Recalls TheraCath Epidural Catheterization Kits

    Arrow International is recalling TheraCath Epidural Catheterization Kits because the included loss of resistance syringes may fail, potentially causing dural puncture.

    Product
    TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1174-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
    Category
    Medical Device
    Distribution
    37 states