BEUDAMED
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    illumina Model NextSeq 550 Dx REF 20005715

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    dsDNA IgG ELISA 96 Well Kit, Catalog Number: DD037G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LRM·August 27, 2008

    Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LRM·March 2, 2010

    Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LRM·March 2, 2010

    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·December 1, 2017

    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Stryker Orthopaedics; Howmedica Osteonics Copr. 325 Corporate Drive Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HRY·November 25, 2008

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023

    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

    FDA Recall
    Terminated ·Zoll Circulation, Inc.·Product code DRM·August 8, 2012

    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

    FDA Recall
    Open, Classified ·ZOLL Circulation, Inc.·Product code DRM·September 22, 2022

    Michigan Instruments Thumper Mechanical CPR Device; Model 1007.

    FDA Recall
    Terminated ·Michigan Instruments, Inc.·Product code DRM·August 4, 2006

    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

    FDA Recall
    Terminated ·Zoll Circulation, Inc.·Product code DRM·July 16, 2013

    LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

    FDA Recall
    Open, Classified ·Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden·Product code DRM·May 21, 2025

    LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevagen 17 SE-223 70 LUND Sweden***www.jolife.com***". Designed to uninterrupted chest compressions at a consistent rate and depth.

    FDA Recall
    Terminated ·Jolife AB Ideon, Scheelev·Product code DRM·February 8, 2011

    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

    FDA Recall
    Terminated ·Michigan Instruments, Inc.·Product code DRM·February 13, 2018

    RMU-2000 Automated Chest Compression Device

    FDA Recall
    Open, Classified ·Defibtech, LLC·Product code DRM·July 12, 2024

    Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

    FDA Recall
    Terminated ·Zoll Circulation, Inc.·Product code DRM·January 28, 2008

    Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

    FDA Recall
    Open, Classified ·Remel Europe Ltd. Clipper Boulevard West Ken Dartford United Kingdom·Product code GRM·March 25, 2026

    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

    FDA Recall
    Open, Classified ·ZOLL Circulation, Inc.·Product code DRM·March 4, 2025