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.

1201–1225 of 1800

  • HighFDA (Devices)·Z-1371-2018·2018-04-18

    Hamilton-C2 Ventilator Units Recalled Due to Battery Fuel Gauge Inaccuracy

    Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.

    Product
    Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1354-2018·2018-04-18

    Bard Premature Infant Feeding Tube Recalled for Ineffective Fusion

    C.R. Bard is recalling 42,200 units of Bard Premature Infant Feeding Tubes due to potentially ineffective fusion between the tubing and the ENFit connector.

    Product
    Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tub
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1357-2018·2018-04-18

    Bard Premature Infant Feeding Tubes Recalled for Ineffective Fusion

    C.R. Bard is recalling specific lots of Bard Premature Infant Feeding Tubes because the tubing and ENFit connector may not be effectively fused.

    Product
    Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tub
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1175-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2018·2018-04-04

    St. Jude Medical Recalls Proclaim DRG Implantable Pulse Generators

    St. Jude Medical is recalling 17 Proclaim DRG Implantable Pulse Generators due to error messages during routine checks and transient overstimulation causing patient discomfort.

    Product
    Proclaim DRG Implantable Pulse Generator, Model Number 3664
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1237-2018·2018-04-04

    Signia Power Handle Recalled for Shutting Down During Surgical Use

    Covidien LLC is recalling 2,121 Signia Power Handles because they reportedly shut down during use. The devices are used in various surgical procedures.

    Product
    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2018·2018-03-28

    Medfusion Syringe Pumps Recalled for Syringe Misidentification Risk

    Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2018·2018-03-28

    Smiths Medical Recalls Medfusion Syringe Pumps Due to Syringe Recognition Issues

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.

    Product
    Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2018·2018-03-28

    Smiths Medical Medfusion Syringe Pumps Recalled for Syringe Misidentification

    Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, preventing proper programming.

    Product
    Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1144-2018·2018-03-28

    Merit Medical Recalls Custom Dialysis Kits with Incorrect Catheter Configuration

    Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-cuff products.

    Product
    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1105-2018·2018-03-28

    Smith & Nephew Legion HK Femoral Wedge Recall Due to Incorrect Screw Size

    Smith & Nephew is recalling Legion HK Femoral Wedge components because the included screws are 5 mm instead of 10 mm, making them too short for use.

    Product
    smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age,
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0843-2018·2018-03-14

    Toshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect

    Toshiba American Medical Systems Inc is recalling 19 INFX-8000C Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.

    Product
    INFX-8000C Fluoroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0900-2018·2018-03-14

    Medtronic BIO CAL Temperature Controller Recalled Due to Cleaning Protocol Issues

    Medtronic is recalling BIO CAL Temperature Controllers because it cannot develop a cleaning protocol that meets current industry standards. Users are advised to discontinue use and dispose of the devices.

    Product
    BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2018·2018-03-07

    DePuy Mitek Recalls FMS Gravity Tube Sets Due to Leakage

    DePuy Mitek is recalling FMS Gravity Tube Sets because they may leak at the bulb and tube connection during arthroscopic procedures.

    Product
    1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0589-2018·2018-02-28

    Medtronic Visia AF ICDs Recalled for Potential Therapy Failure

    Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0639-2018·2018-02-28

    Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error

    Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0586-2018·2018-02-28

    Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk

    Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0637-2018·2018-02-28

    DeRoyal recalls custom sterile surgical packs with Terumo valve defect

    DeRoyal Industries Inc is recalling 181 custom sterile surgical packs distributed in New York due to a Terumo valve defect causing no flow.

    Product
    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0686-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2018·2018-02-28

    Synthes LCP Drill Sleeve Recall Due to Connection and Alignment Issues

    Synthes, Inc. is recalling LCP Drill Sleeve 1.5 Drill Bits because they may fail to attach to plates, potentially causing surgical delays or off-center drilling.

    Product
    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0685-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2018·2018-02-21

    3M Bair Hugger Underbody Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger Normothermia System blankets due to a design change that may cause unintended airflow occlusion and limited inflation.

    Product
    3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2018·2018-02-21

    3M Bair Hugger Warming Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger warming blankets because a design change may cause airflow blockage, leading to limited inflation during use.

    Product
    3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort
    Category
    Medical Device
    Distribution
    Distributed nationwide