BEUDAMED
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    ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

    FDA Recall
    Open, Classified ·Swissray Medical Hohenrainstrasse 61 Hochdorf Switzerland·Product code KPR·November 18, 2016

    ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

    FDA Recall
    Open, Classified ·Swissray Medical Hohenrainstrasse 61 Hochdorf Switzerland·Product code KPR·August 9, 2016

    Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

    FDA Recall
    Open, Classified ·Immuno-Mycologics, Inc·Product code PPM·March 26, 2026

    Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256

    FDA Recall
    Terminated ·Product code DXY·November 4, 2002

    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

    FDA Recall
    Terminated ·Materialise USA LLC·Product code HRY·November 26, 2013

    Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code NIK·May 5, 2010

    Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DDR·September 27, 2007

    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015

    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code DDR·March 5, 2018

    ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DDR·October 17, 2005

    Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code DDR·August 8, 2016

    The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DDR·July 2, 2019

    ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code DDR·February 21, 2024

    AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20

    FDA Recall
    Terminated ·Abbott Laboratories·Product code DDR·January 19, 2009

    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015

    Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DDR·April 3, 2006

    AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code DDR·April 23, 2007

    Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code DDR·April 3, 2006

    ALTRUA 2 DR Pacemaker

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code LWP·December 7, 2017

    Model Number S722, ALTRUA 2 DR EL Pacemaker

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code LWP·August 20, 2025