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    PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HTW·February 22, 2008

    PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01

    FDA Recall
    Terminated ·Phadia US Inc·Product code LSW·December 14, 2020

    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    FDA Recall
    Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017

    LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

    FDA Recall
    Open, Classified ·LSL Healthcare Inc.·Product code OXQ·March 9, 2026

    LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

    FDA Recall
    Open, Classified ·LSL Healthcare Inc.·Product code OXQ·March 9, 2026

    LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

    FDA Recall
    Open, Classified ·LSL Healthcare Inc.·Product code OXQ·March 9, 2026

    LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

    FDA Recall
    Open, Classified ·LSL Healthcare Inc.·Product code OIB·March 9, 2026

    LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

    FDA Recall
    Open, Classified ·LSL Healthcare Inc.·Product code OVN·March 9, 2026

    LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

    FDA Recall
    Open, Classified ·LSL Healthcare Inc.·Product code OWL·December 22, 2025

    LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

    FDA Recall
    Open, Classified ·LSL Healthcare Inc.·Product code LRS·March 9, 2026

    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Recall
    Terminated ·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016

    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    FDA Recall
    Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

    RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use

    FDA Recall
    Terminated ·Ability Dynamics LLC·Product code ISW·June 2, 2014

    Polyflex Esophageal Stent 20/16mm x 90mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Polyflex Esophageal Stent 20/16mm x 120mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·July 15, 2010