Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 361–380 of 1,000 recalls

Class ITerminated

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260

Edwards Lifesciences, LLC

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

July 9, 2019 · DeviceView details →
Class ITerminated

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246

Edwards Lifesciences, LLC

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

July 9, 2019 · DeviceView details →
Class ITerminated

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253

Edwards Lifesciences, LLC

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

July 9, 2019 · DeviceView details →
Class ITerminated

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239

Edwards Lifesciences, LLC

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

July 9, 2019 · DeviceView details →
Class ITerminated

Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volumat MC Agilia infusion pumps. Intended patient population: The Vigilant Drug Lib software must only be used to create drug libraries for patients whose weight is 250g to 250 kg (0.6 lbs. to 551 lbs.).

Fenwal Inc

The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib

June 24, 2019 · DeviceView details →
Class ITerminated

VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. Volumat MC Agilia can be used with the Dose Error Reduction Software (DERS) Vigilant Drug Lib to define the default and upper hard limits for the Bolus Volume, or dose, by drug. The health care professional can then operate the pump for that drug within the upper hard limits defined in the Drug Library.

Fenwal Inc

The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib

June 24, 2019 · DeviceView details →
Class ITerminated

ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)

St Jude Medical Inc.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

June 20, 2019 · DeviceView details →
Class ITerminated

ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

St Jude Medical Inc.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

June 20, 2019 · DeviceView details →
Class ITerminated

ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

St Jude Medical Inc.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

June 20, 2019 · DeviceView details →
Class ITerminated

ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

St Jude Medical Inc.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

June 20, 2019 · DeviceView details →
Class ITerminated

ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

St Jude Medical Inc.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

June 20, 2019 · DeviceView details →
Class ITerminated

ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

St Jude Medical Inc.

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

June 20, 2019 · DeviceView details →
Class ITerminated

Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

TELEFLEX-MORRISVILLE

Device vented gas below the stated pressure.

June 14, 2019 · DeviceView details →
Class ITerminated

Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.

Centurion Medical Products Corporation

Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.

June 7, 2019 · DeviceView details →
Class ITerminated

Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

Qiagen Sciences LLC

Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)

June 5, 2019 · DeviceView details →
Class ITerminated

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

Galemed Corporation

Reports of pressure relief manifold venting gas below the standard pressure.

May 30, 2019 · DeviceView details →
Class ITerminated

Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

Galemed Corporation

Reports of pressure relief manifold venting gas below the standard pressure.

May 30, 2019 · DeviceView details →
Class ITerminated

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Galemed Corporation

Reports of pressure relief manifold venting gas below the standard pressure.

May 30, 2019 · DeviceView details →
Class ITerminated

Quantum Pump Console

Spectrum Medical Ltd.

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

May 29, 2019 · DeviceView details →
Class ITerminated

Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management

Teleflex Medical

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

May 24, 2019 · DeviceView details →
← PreviousPage 19 of 50Next →