The Recall Desk

Manufacturer

Olympus Corporation of the Americas

415 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.

What the numbers show

Total
415
Critical
27
Severe
40
Most recent
2026-09-02

Of the 415 recalls from Olympus Corporation of the Americas we have scored against our rubric, 27 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 40 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

351–375 of 415

  • HighFDA (Devices)·Z-0507-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Reduction

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk

    Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning instructions.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0119-2021·2020-10-28

    Olympus Choledoscope Recalled for Lack of Clearance and Breakage

    Olympus is recalling CHF-CB30S choledoscopes because they lack FDA clearance and have experienced breakage and metal protrusion during use.

    Product
    Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3017-2020·2020-10-07

    Olympus BF-Q180 Bronchovideoscope Recalled for Infection Risk and Regulatory Issues

    Olympus is recalling BF-Q180 bronchovideoscopes because they lack 510(k) clearance and are associated with a higher rate of patient infections.

    Product
    Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2813-2020·2020-08-26

    Olympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices

    Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston due to outer carton mislabeling.

    Product
    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2814-2020·2020-08-26

    Olympus Smart Stapes Protheses Piston Recalled for Mislabeled Outer Carton

    Olympus is recalling 21 units of Smart Stapes Protheses Piston because the outer carton was mislabeled, potentially containing a different model.

    Product
    Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2292-2020·2020-06-17

    Olympus ENF-GP2 Fiberscope Recalled for Missing O Ring

    Olympus is recalling 19 ENF-GP2 Rhino-Laryngo Fiberscopes because they may be missing an O ring after being repaired with an incorrect service manual.

    Product
    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2020·2020-06-10

    Olympus ShockPulse-SE Lithotripsy Transducers Recalled for Material Defect

    Olympus is recalling 18 ShockPulse-SE Lithotripsy System transducers because a component was made with non-conforming material that could allow water ingress during sterilization.

    Product
    OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1762-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Missing Compatibility Data

    Olympus Corporation of the Americas is recalling 265 Pleuravideoscope Model LTF-160 units because data validating compatibility with certain endo-therapy devices was missing.

    Product
    Olympus Pleuravideoscope, Model LTF-160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1763-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Compatibility Data Gaps

    Olympus is recalling 265 Pleuravideoscope units because data validating compatibility with certain endo-therapy devices was missing. Updated manuals are being provided.

    Product
    Olympus Pleuravideoscope, Model LTF-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2020·2019-10-23

    Olympus Berkeley Disposa-Filter Recall Due to Weld Defect

    Olympus is recalling Berkeley Disposa-Filters used with the VC-10 Vacuum Curettage System because an ultrasonic weld defect may cause the housing to separate.

    Product
    Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2019·2019-08-14

    Olympus MAJ-209 Single Use Suction Valves Recalled for Potential Malfunction

    Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2019·2019-07-24

    Olympus Mobile Workstations Recalled for Potential Instability

    Olympus is recalling WM-NP2 and WM-DP2 mobile workstations because the control panel arm may cause the unit to fall over if a heavy monitor is attached.

    Product
    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1008-2019·2019-03-20

    Olympus GIF-H180J Gastrointestinal Videoscope Recalled Due to Adhesive Error

    Olympus is recalling one GIF-H180J videoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.

    Product
    Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1009-2019·2019-03-20

    Olympus PCF-Q180AC Video Colonoscope Recalled Due to Adhesive Error

    Olympus is recalling two video colonoscopes because the adhesive used in their repair was incorrectly prepared, potentially affecting the durability of the repair.

    Product
    Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2019·2019-03-20

    Olympus TJF-Q180V Duodenoscope Recalled Due to Adhesive Preparation Error

    Olympus is recalling two TJF-Q180V duodenoscopes because the adhesive used in their repair was incorrectly prepared, potentially affecting the device's durability or effectiveness.

    Product
    Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1007-2019·2019-03-20

    Olympus Ultrasound Gastrovideoscope Recalled Due to Adhesive Preparation Error

    Olympus is recalling one ultrasound gastrovideoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.

    Product
    Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide