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.

1276–1300 of 1800

  • HighFDA (Devices)·Z-2605-2017·2017-06-28

    Medtronic Recalls MiniMed 670G Insulin Pumps Due to Keypad Issues

    Medtronic is recalling 117,239 MiniMed 670G insulin pumps because the keypad may become unresponsive and the pump may become temporarily stuck.

    Product
    MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2603-2017·2017-06-28

    Medtronic Recalls MiniMed 630G Insulin Pumps Due to Keypad Malfunction

    Medtronic is recalling 65,959 MiniMed 630G insulin pumps because the device may become temporarily stuck and the keypad may become unresponsive.

    Product
    MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2299-2017·2017-06-14

    Arrow Arterial Catheterization Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2302-2017·2017-06-14

    Arrow Arterial Line Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling Arterial Line Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2017·2017-06-14

    Circadiance Recalls SmartMonitor 2 PS/PSL Apnea Monitors for Nurse Call Defect

    Circadiance LLC is recalling 1,242 SmartMonitor 2 PS/PSL apnea monitors because the nurse call feature may operate intermittently, potentially preventing alarm transmission.

    Product
    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2017·2017-06-14

    ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Valve Defect

    ConvaTec is recalling specific lots of pediatric oxygen masks because the check valve may not function correctly, potentially affecting oxygen delivery.

    Product
    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2122-2017·2017-05-31

    Cardiovascular Systems Recalls Orbital Atherectomy System Saline Infusion Pumps

    Cardiovascular Systems Inc. is recalling 1,396 Saline Infusion Pumps that may switch to stand-by during use, requiring a reset to continue treatment.

    Product
    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2117-2017·2017-05-31

    Medtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices

    Medtronic is recalling specific MRI-conditional CRT-D devices due to an unexpected transient mode switch behavior detected during systems testing.

    Product
    Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2053-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2038-2017·2017-05-24

    Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues

    Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2037-2017·2017-05-24

    Abbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Trek RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2039-2017·2017-05-24

    Abbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues

    Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheters because the protective sheath may be difficult to remove, potentially affecting balloon inflation or deflation.

    Product
    NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1928-2017·2017-05-10

    Dale Medical Stabilock Endotracheal Adhesive Base Recalled for Adhesive Failure

    Dale Medical Products is recalling Stabilock Endotracheal Adhesive Bases because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.

    Product
    Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that atta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2017·2017-05-10

    Dale Medical Stabilock Endotracheal Tube Holder Recall for Adhesive Failure

    Dale Medical Products is recalling Stabilock Endotracheal Tube Holders because the adhesive faceplate may lose its properties and fail to adhere to the patient's face.

    Product
    Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attach
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1832-2017·2017-05-03

    HeartWare HVAD Pump Driveline Splice Kit Recall for Improved Repair

    Medtronic is notifying clinicians that an improved splice kit is available to replace the HeartWare HVAD Pump Driveline Splice Kit due to a safety issue.

    Product
    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit si
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2017·2017-04-26

    Siemens Artis zee Angiographic X-ray System Software Recall

    Siemens is recalling three Artis zee angiographic x-ray systems due to a software fault that prevents the system from initializing after a tube assembly failure.

    Product
    Artis zee, Angiographic x-ray system
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1776-2017·2017-04-19

    Volcano Recalls Refinity Short Tip Rotational IVUS Catheters Due to Kinking

    Volcano Corporation is recalling 718 Refinity Short Tip Rotational IVUS Catheters due to high complaint rates of kinking near the proximal shaft junction, which may disrupt clinical workflow or cause loss of imaging.

    Product
    Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examina
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1769-2017·2017-04-19

    Datascope Recalls Custom Tubing Packs Due to Assembly Error

    Datascope Corporation is recalling 21 custom tubing packs with Bioline coating due to a reported assembly error on the oxygenator line.

    Product
    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterili
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1775-2017·2017-04-19

    Volcano Recalls Refinity Rotational Intravascular Ultrasound Catheters Due to Kinking

    Volcano Corporation is recalling 718 Refinity Rotational Intravascular Ultrasound Catheters because high complaint rates indicate kinking near the proximal shaft, which could disrupt clinical workflow or cause loss of imaging.

    Product
    Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of co
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1711-2017·2017-04-12

    Beckman Coulter Recalls UniCel DxC 600i SYNCHRON Access Clinical Systems

    Beckman Coulter is recalling specific UniCel DxC 600i SYNCHRON Access Clinical Systems because a circuit board defect can cause the device to stop running and cancel tests.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentr
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1692-2017·2017-04-05

    UOC Femoral Driver Recalled Due to Locking Lever Pin Breakage Risk

    United Orthopedic Corporation is recalling 33 UOC Femoral Drivers because the locking lever pin may deform and break, causing the device to malfunction during surgery.

    Product
    UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1694-2017·2017-04-05

    Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump

    Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.

    Product
    SynchroMed II implantable drug infusion pump, Model 8637-40,
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1477-2017·2017-03-22

    C2 CryoBalloon Controller Cap Recall Due to Cracking Risk

    C2 Therapeutics is recalling 755 C2 CryoBalloon Controller Caps because they may crack when tightened, potentially compromising the device's integrity.

    Product
    C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2017·2017-03-15

    Parker Medical Recalls Left Double Lumen Endobronchial Tubes

    Parker Medical is recalling specific lots of Left Double Lumen Endobronchial Tubes because the single lung isolation feature did not function as intended.

    Product
    Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolat
    Category
    Medical Device
    Distribution
    Distributed nationwide