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    Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom·Product code MWJ·November 25, 2024

    Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom·Product code MWJ·November 25, 2024

    Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

    FDA Recall
    Terminated ·Braemar Manufacturing, LLC·Product code MWJ·January 22, 2020

    Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Configuration - 453564067171 96-Hour Configuration - 453564067181 7-Day Configuration Model Number: 860322

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MWJ·January 13, 2020

    Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only

    FDA Recall
    Terminated ·Braemar Manufacturing, LLC·Product code MWJ·January 22, 2020

    Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666

    FDA Recall
    Open, Classified ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FDS·July 27, 2023

    Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code ODC·February 12, 2026

    Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code ODC·February 12, 2026

    Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·February 12, 2026

    Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·February 12, 2026

    Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FBN·December 18, 2024

    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·January 16, 2024

    The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEB·July 12, 2023

    Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDT·December 8, 2023

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FDT·April 18, 2023

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·April 1, 2019

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEM·June 10, 2019

    ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·September 11, 2008