The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) 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 device malfunction 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.

751–775 of 1800

  • HighFDA (Devices)·Z-0458-2022·2022-01-12

    UROMEDICA Implantation Instrument Sheath May Damage ProACT Implants

    Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.

    Product
    UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2022·2022-01-05

    Ultimum Hemostasis Introducer devices recalled due to manufacturing error

    Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.

    Product
    Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2022·2022-01-05

    Diagnostic test kit recalled due to substrate error preventing test execution

    A diagnostic test kit manufactured by bioMerieux has been recalled because a substrate error prevents the test from running, which delays test results for patients.

    Product
    VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2022·2021-12-29

    Nurse Call Communication System Components May Fail to Reboot

    Hill-Rom's NaviCare and Voalte nurse call communication systems may experience an unrecoverable software error causing components to fail reboot cycles and become non-functional, requiring replacement.

    Product
    These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten

    Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0339-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect

    Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980A3ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2022·2021-12-08

    Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

    Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.

    Product
    HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect

    Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.

    Product
    HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

    Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss

    Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.

    Product
    HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2022·2021-12-08

    FDA Recalls Hurricane RX Dilation Balloons for Pressure Failure Risk

    Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic procedures.

    Product
    HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2022·2021-12-08

    Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss

    Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.

    Product
    HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0290-2022·2021-12-01

    Endurant Stent Graft System spindle detachment during deployment

    Medtronic recalls 2 Endurant Stent Graft System devices due to potential spindle detachment from the hypotube during surgical deployment. The mechanical failure could affect graft positioning.

    Product
    Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2022·2021-12-01

    Medtronic Wireless Recharger for Activa RC May Become Unresponsive

    Medtronic wireless rechargers for the Activa RC neurostimulator may become unresponsive if charging instructions from the patient user guide are not precisely followed. Approximately 6,406 devices are affected nationwide.

    Product
    Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2022·2021-12-01

    Medtronic Endurant II Stent Graft Systems Recalled Due to Potential Spindle Detachment

    Medtronic is recalling 511 Endurant II Stent Graft Systems because during deployment, the spindle may detach from the distal end of the spindle hypotube.

    Product
    Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2022·2021-12-01

    Siemens Artis Zee Biplane X-ray Imaging System Software Malfunction

    Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, resulting in procedural delays.

    Product
    Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2022·2021-12-01

    Siemens Artis Q floor angiography system: X-ray failure during SID lift operation

    Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.

    Product
    Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2022·2021-12-01

    Siemens Artis Q.zen Angiography System May Fail to Fire X-rays During Simultaneous Operations

    Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.

    Product
    Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2022·2021-11-24

    LEEP PRECISION Integrated System may fail to coagulate during surgery

    CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.

    Product
    LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2022·2021-11-24

    LEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure

    CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.

    Product
    LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2022·2021-11-24

    LEEP PRECISION Electrosurgical System Coagulation Function May Fail

    CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.

    Product
    LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2022·2021-11-24

    Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect

    Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.

    Product
    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0261-2022·2021-11-24

    Quantum 2000 Electrosurgical Generator Hand Switch Coagulation Failure

    CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2022·2021-11-17

    Safety Blood Collection Needle Recalled for Safety Mechanism Activation Issues

    Zhejiang Kindly Medical Devices is recalling Henry Schein Safety Blood Collection Needles due to potential difficulty activating the safety mechanism. Affected lot numbers distributed nationwide.

    Product
    HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
    Category
    Medical Device
    Distribution
    Distributed nationwide