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    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc·Product code PFV·December 22, 2022

    VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS

    FDA Recall
    Open, Classified ·Product code GCJ·March 22, 2023

    Exactech Ergo Impactor Handle, Catalog #321-09-05.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code HWA·June 5, 2023

    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code OLO·June 5, 2023

    Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·May 19, 2023

    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MKJ·May 3, 2018

    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·June 21, 2018

    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code DYB·September 28, 2016

    IMRIS T2X Table, Part Number 109682-600

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code FQO·February 20, 2018

    Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FMI·June 21, 2017

    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016

    ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·April 22, 2024

    ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code HNN·April 22, 2024

    ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JJE·August 19, 2014

    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016

    Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016

    Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FMI·June 21, 2017

    Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DHR·November 6, 2019

    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·April 13, 2026

    Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·March 3, 2021