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    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

    FDA Recall
    Terminated ·Cook Inc.·Product code GBO·December 27, 2019

    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FGE·May 15, 2024

    Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FGE·May 15, 2024

    Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code CGA·August 16, 2022

    STAR S4 IR Excimer Laser System; Software Version 5.15 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.

    FDA Recall
    Terminated ·Visx Inc·Product code LZS·May 30, 2007

    LADARVision Excimer Laser System.

    FDA Recall
    Terminated ·Alcon Laboratories, Inc.·Product code LZS·August 1, 2005

    STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code LZS·May 28, 2013

    STAR S4 IR Excimer Laser System; Software Version 5.22 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.00 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    DIST LAT FEM LOCK PLT, LT

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code FZS·November 5, 2013

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code FZS·December 3, 2024

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Recall
    Terminated ·Illumina Inc·Product code PFS·November 6, 2014

    STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code LZS·May 28, 2013

    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    FDA Recall
    Terminated ·Nidek Inc·Product code LZS·February 1, 2017