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    Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FAJ·September 25, 2023

    Visera Hysterovideoscope Olympus HYF Type V

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HIH·July 20, 2023

    Model No. CYF-V2, VISERA Cysto-Nephro Videoscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-5, Cystonephrofiberscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-5R, Cystonephrofiberscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope

    FDA Recall
    Open, Classified ·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023

    Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FAJ·April 20, 2022

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MWS·August 13, 2014

    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;

    FDA Recall
    Open, Classified ·Product code OEZ·January 7, 2026

    ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MWS·November 16, 2011

    IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FMG·October 2, 2025

    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code HIH·September 25, 2023

    Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code HIH·September 25, 2023

    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRS·March 31, 2021