BEUDAMED
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    rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

    FDA Recall
    Terminated ·Generic Medical Devices·Product code FTL·June 18, 2009

    Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

    FDA Recall
    Terminated ·Leica Biosystems Imaging, Inc.·Product code NOT·December 10, 2018

    ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver with everyday patient handling routines, such as bed and chair related transfers. REF MFA1000M-L-L1 RM0255_7

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FSA·October 22, 2018

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LWS·September 10, 2018

    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone Industrielle des Fourneaux Sees France·Product code JIX·April 18, 2017

    Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018

    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code NEW·January 10, 2018

    PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code NEW·January 10, 2018

    SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018

    DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.

    FDA Recall
    Terminated ·GE Healthcare Biosciences·Product code REM·September 10, 2018

    Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018

    Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018

    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code NEW·January 10, 2018

    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·December 10, 2018

    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·December 10, 2018

    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·December 10, 2018

    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·December 10, 2018

    Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.

    FDA Recall
    Terminated ·A M Systems Inc·Product code BYX·August 10, 2018

    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCW·January 10, 2017