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.

451–475 of 881

  • HighFDA (Devices)·Z-2203-2019·2019-08-14

    Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk

    Medline Industries is recalling endoscopic cleaning brushes because they may detach during use, potentially leaving parts inside endoscopes.

    Product
    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

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

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

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

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2019·2019-08-07

    Centurion Recalls Sheridan Endotracheal Tubes for Connector Disconnection

    Centurion Medical Products is recalling 80 Sheridan Endotracheal Tubes due to an increased incidence of the connector becoming disconnected from the tube.

    Product
    Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1977-2019·2019-07-24

    FDA Recalls Advincula Delineator Uterine Manipulator Due to Cracking Risk

    CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.

    Product
    Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1986-2019·2019-07-24

    Clariance Erisma-LP Posterior Fixation System Recalled for Screw Disassembly Risk

    Clariance Inc is recalling Erisma-LP posterior fixation system components due to a potential for polyaxial screws to disassemble during implantation.

    Product
    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrenc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1874-2019·2019-07-17

    Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Ambient State Risk

    Hamilton Medical is recalling 4,338 HAMILTON-G5 ventilators with software versions 2.60 or lower because they may enter an ambient state, requiring immediate alternative ventilation.

    Product
    HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2019·2019-07-10

    ZOLL AED PRO Defibrillators Recalled for Potential Energy Delivery Failure

    ZOLL Medical Corporation is recalling 1,969 AED PRO units because they may fail to deliver energy to patients during cardiac arrest.

    Product
    ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1757-2019·2019-06-26

    Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

    Cook Inc. is recalling 131 Advance Enforcer 35 Focal Force PTA Balloon Catheters because multiple complaints reported the balloons bursting below their rated pressure.

    Product
    Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in periphe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1756-2019·2019-06-26

    Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

    Cook Inc. is recalling 34 Advance Enforcer 35 Focal Force PTA Balloon Catheters because they may burst below the rated pressure, posing risks of vessel injury and balloon fragmentation.

    Product
    Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in periphe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2019·2019-06-12

    Flowonix Prometra II Pump Recall for Unexpected Shutdowns

    Flowonix Medical Inc. is recalling 163 Prometra II Programmable Pumps due to a software defect that can cause unexpected shutdowns.

    Product
    Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2019·2019-06-12

    Microline TLS2 Thermal Ligating Shears Recalled for Actuation Failure

    Microline Surgical is recalling 115 TLS2 Thermal Ligating Shears because they fail to actuate, preventing them from performing their intended surgical function.

    Product
    TLS2 Thermal Ligating Shears, Catalog Number 132-131D
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1117-2019·2019-05-01

    Edwards Miller Balloon Atrioseptostomy Catheter Recalled for Deflation Issues

    Edwards Lifesciences is recalling Miller Balloon Atrioseptostomy Catheters due to difficulty deflating the balloon and reports of fragmentation or detachment.

    Product
    Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2019·2019-04-17

    BD Blood Collection Assembly Recalled for Luer Breakage Risk

    Becton Dickinson is recalling 6.5 million blood collection assemblies because the luer could break, causing leaks or blocking dialysis ports.

    Product
    BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1066-2019·2019-04-03

    Beaver Visitec Soft Tip Cannula Recall for Missing Protective Sheath

    Beaver Visitec is recalling specific lots of Soft Tip Cannulas because a missing protective sheath may cause the silicone tip to break or detach during eye procedures.

    Product
    BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2019·2019-04-03

    Fenwal CATSmart Vacuum Unit Recalled for Potential Failure During Use

    Fenwal Inc is recalling 198 Vacuum Units for the CATSmart system because they may stop working and display a failure message during use.

    Product
    Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1008-2019·2019-03-20

    Olympus GIF-H180J Gastrointestinal Videoscope Recalled Due to Adhesive Error

    Olympus is recalling one GIF-H180J videoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.

    Product
    Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1007-2019·2019-03-20

    Olympus Ultrasound Gastrovideoscope Recalled Due to Adhesive Preparation Error

    Olympus is recalling one ultrasound gastrovideoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.

    Product
    Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2019·2019-03-20

    Olympus TJF-Q180V Duodenoscope Recalled Due to Adhesive Preparation Error

    Olympus is recalling two TJF-Q180V duodenoscopes because the adhesive used in their repair was incorrectly prepared, potentially affecting the device's durability or effectiveness.

    Product
    Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0627-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement

    FDA is recalling the Covidien Emprint Standard Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2019·2018-12-26

    Jarvik 2000 Ventricular Assist System External Cables Recalled for Connector Damage

    Jarvik Heart Inc is recalling 274 external cable components for the Jarvik 2000 Ventricular Assist System due to potential damage to male connectors.

    Product
    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0598-2019·2018-12-19

    Neotract Recalls UroLift System Due to Capsular Tab Delivery Failure

    Neotract is recalling UroLift System devices because the capsular tab may fail to deploy, potentially delaying or preventing treatment completion.

    Product
    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0521-2019·2018-12-05

    GE Healthcare Recalls Dash 5000 Patient Monitoring Systems

    GE Healthcare is recalling approximately 182,640 Dash 5000 Patient Monitoring Systems because they may simultaneously restart during prolonged network overloads.

    Product
    Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0474-2019·2018-11-28

    Boston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions

    Boston Scientific is recalling 12,900 SQ-RX Pulse Generators used in S-ICD systems due to latent internal battery malfunctions that cause accelerated depletion.

    Product
    The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have sympto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2019·2018-11-14

    Oscor TB Series Bipolar Pacing Leads Recalled for Connector Sliding

    Oscor, Inc. is recalling TB Series Bipolar Pacing Leads because the connector cap housing may slide, potentially exposing the connection wire and causing loss of pacing.

    Product
    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tr
    Category
    Medical Device
    Distribution
    Distributed nationwide