BEUDAMED
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    PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

    PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

    Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

    Pentax Medical Video Processor; Model Number: EPK-i8020c;

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·July 16, 2025

    Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code FDF·July 14, 2021

    Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code FDF·July 14, 2021

    BF-MP160F: EVIS EXERA Bronchofibervideoscope

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·March 8, 2022

    Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·June 8, 2023

    Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·June 8, 2023

    Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code PKL·May 4, 2023

    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·October 12, 2023

    Olympus Bronchovideoscope, Models BF-XT190.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·July 27, 2023

    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·December 4, 2023

    ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FAS·October 2, 2023

    Colonoscope, Model Number PCF-H190L.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDF·January 11, 2024

    Colonoscope, Model Number PCF-H180AL.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code NWB·January 11, 2024

    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FGE·November 10, 2023

    SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·December 1, 2023

    POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEI·March 7, 2024

    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

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