BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.

    FDA Recall
    Terminated ·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020

    Vl DBL OFFST WI LRG STPL, RT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    Depuy brand LCS Complete metal backed patella, cemented, LRG; REF 1294-09-760.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    Depuy brand LCS Complete metal backed patella, porocoat, LRG+; REF 1294-09-670.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    Depuy brand LCS Complete metal backed patella, porocoat, LRG; REF 1294-09-660.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    Depuy brand LCS Complete metal backed patella, cemented, LRG+; REF 1294-09-770.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·June 7, 2005

    INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HSB·October 11, 2013

    Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No App; 540D/ OB RESOLVE COMPONENT TRAY

    FDA Recall
    Terminated ·Ossur Americas·Product code HAX·June 21, 2018

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LRG·June 2, 2014

    MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·December 2, 2020

    MicroScan WalkAway-96 plus Reconditioned Instrument

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·September 4, 2019

    MicroScan WalkAway-40 plus Instrument

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·September 4, 2019

    MicroScan WalkAway-96 plus Instrument

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·September 4, 2019

    MicroScan WalkAway-40 plus Reconditioned Instrument

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LRG·September 4, 2019

    Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT LG-No App; 540C/ CB RESOLVE COMPONENT TRAY; 553CB/ CB RING TRAY SM; 554CB/ CB RING TRAY STD; 555CB/ CB RING TRAY LG; 505301C/ Kit Closed Back Halo Sm; 505401C/ Kit Closed Back Halo Md; 505501C/ Kit Closed Back Halo Lg

    FDA Recall
    Terminated ·Ossur Americas·Product code HAX·June 21, 2018

    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LTT·May 2, 2013

    CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Recall
    Terminated ·DRG International, Inc.·Product code JKD·December 21, 2021