BEUDAMED
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    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·May 27, 2021

    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

    FDA Recall
    Terminated ·Covidien LLC·Product code FSY·April 16, 2015

    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 25, 2021

    MAS Omni Immune Controls

    FDA Enforcement
    Class III ·Terminated·Microgenics Corporation·July 2, 2014

    MAS Omni Immune PRO Controls

    FDA Enforcement
    Class III ·Terminated·Microgenics Corporation·July 2, 2014

    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·February 11, 2015

    MAS Omni Immune Controls

    FDA Recall
    Terminated ·Microgenics Corporation·Product code JJY·December 2, 2013

    MAS Omni Immune PRO Controls

    FDA Recall
    Terminated ·Microgenics Corporation·Product code JJY·December 2, 2013

    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

    FDA Enforcement
    Class II ·Terminated·COVIDIEN LLC·October 10, 2018

    White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GGK·December 19, 2007

    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·January 15, 2015

    ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.

    FDA Recall
    Terminated ·Baxter Corporation Englewood·Product code NEP·April 8, 2015

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    FDA Enforcement
    Class II ·Terminated·New Era Orthopaedics, LLc·August 15, 2018

    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·May 2, 2018

    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·May 2, 2018

    Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy

    FDA Recall
    Terminated ·ela Medical Llc·Product code NIK·June 7, 2010

    LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·May 19, 2005

    ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142

    FDA Recall
    Terminated ·Esa Biosciences, Inc.·Product code DOF·September 20, 2007

    Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.

    FDA Recall
    Terminated ·ela Medical Llc·Product code MRM·July 19, 2005