BEUDAMED
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    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LFL·November 25, 2024

    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LFL·November 25, 2024

    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·September 11, 2025

    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code EOQ·September 11, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·March 25, 2026

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·March 25, 2026

    Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-JA (Japan Only), TFL-FBX200R-JA (Japan Only), TFL-FBX550R-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·May 6, 2025

    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEI·February 25, 2026

    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code LFL·October 22, 2025

    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·January 7, 2026

    BF-MP60: OES Bronchofiberscope

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

    Soltive Pro SuperPulsed Laser System, Model TFL-SLS

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·May 31, 2024

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEI·September 4, 2024

    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

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

    EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855

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

    EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880

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

    Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 6, 2023

    EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code NAY·April 24, 2024