The Recall Desk

Manufacturer

Olympus Corporation of the Americas

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

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.

176–200 of 337

  • HighFDA (Devices)·Z-0225-2025·2024-10-30

    Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information

    Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.

    Product
    EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0134-2025·2024-10-30

    Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error

    Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.

    Product
    Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2025·2024-10-30

    Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming

    Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.

    Product
    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2025·2024-10-23

    Olympus EVIS EXERA III Video System Recalled for Startup Failure

    Olympus is recalling 45 units of the EVIS EXERA III Video System Center (Model CV-190) that fail to start due to power supply defects. The endoscopy device was distributed nationwide.

    Product
    EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1547-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled for Breaking During Use

    Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1548-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled Due to Breakage During Use

    Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2540-2024·2024-08-14

    Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects

    Olympus is recalling Everest Bipolar Cutting Forceps surgical instruments due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. Affected batches: FR150448, FR154445, FR173022.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2024·2024-08-14

    Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. The recall affects 4,364 units distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2024·2024-08-14

    Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2506-2024·2024-08-14

    Wireless Footswitch for Soltive Laser System Recalled for Pairing Difficulties

    Olympus Corporation of the Americas is recalling 1,838 units of the Soltive SuperPulsed Laser System Wireless Footswitch due to pairing difficulties that may delay surgical procedures.

    Product
    Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2504-2024·2024-08-14

    Soltive Premium SuperPulsed Laser System Wireless Footswitch Pairing Difficulties

    The Soltive Premium SuperPulsed Laser System may experience difficulties pairing its wireless footswitch, potentially delaying surgical procedures. The recall affects units distributed worldwide.

    Product
    Soltive Premium SuperPulsed Laser System, Model TFL-PLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2505-2024·2024-08-14

    Surgical Laser System Recalled Due to Wireless Footswitch Pairing Difficulties

    Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.

    Product
    Soltive Pro SuperPulsed Laser System, Model TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2415-2024·2024-07-31

    Electrosurgical Generators Olympus ESG-410 May Fail to Power On

    Olympus is recalling 86 ESG-410 Electrosurgical Generators because they may fail to power on during use, potentially delaying treatment or prolonging surgery.

    Product
    ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2233-2024·2024-07-10

    Operating Room System Recalled for Incomplete Electrical Safety Testing Records

    Olympus has recalled 227 EasySuite 4K operating room systems worldwide due to incomplete documentation of earth leakage testing, which is required to confirm electrical current levels are within safety standards.

    Product
    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, sur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2024·2024-06-12

    Hysteroscope recalled due to missed required leakage test

    Olympus OES 4000 Hysteroscope Model A4674A is being recalled because a required leakage test was not performed after device repairs. Liquid could enter the eyepiece, causing a foggy image during use.

    Product
    OES 4000 Hysteroscope, Model/Catalog Number: A4674A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2024·2024-05-29

    Olympus InstaClear Lens Sheath Recalled for Potential Distal End Breakage

    Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.

    Product
    InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2024·2024-05-08

    Olympus POWERSEAL Sealer Recalled for Incomplete Seal Malfunction

    Olympus Corporation is recalling the POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider due to a device malfunction where the sealer fails to deliver energy upon activation, resulting in incomplete seal cycles and surgical delay.

    Product
    POWERSEAL 5 mm, 23 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-0523CJDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2024·2024-05-08

    POWERSEAL surgical sealer malfunction causes incomplete seal cycle

    Olympus POWERSEAL surgical sealers may fail to deliver energy upon activation, resulting in incomplete seal cycles and surgical delays. Affected devices display an error tone and message instead of completing the sealing function.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2024·2024-05-08

    Olympus POWERSEAL Surgical Sealer Recalled for Non-Functional Seal Activation

    Olympus POWERSEAL curved jaw sealers may fail to deliver energy during initial activation, causing incomplete seal cycles and surgical delays. Affected units should be removed from service immediately.

    Product
    POWERSEAL 5 mm, 44 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-0544CJDA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2024·2024-04-17

    Olympus Hemostasis Probe Mispackaged with Wrong Connector Type

    Olympus Corporation is recalling 36 units of Hemostasis Probe Model CD-B622LA that were mispackaged with the wrong connector type and labeled incorrectly. Healthcare facilities using the wrong device could experience use errors.

    Product
    Hemostasis Probe, Model: CD-B622LA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1375-2024·2024-04-03

    Olympus Insufflation Unit UHI-4 Recalled for Air Supply Failure

    Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.

    Product
    Insufflation unit, UHI-4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2024·2024-04-03

    Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk

    Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.

    Product
    InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1384-2024·2024-04-03

    SOLTIVE Pro SuperPulsed Laser recalled for non-compliant power cord

    Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.

    Product
    SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1385-2024·2024-04-03

    SOLTIVE Premium SuperPulsed Laser Recalled for Incompatible Power Cord

    Olympus recalls the SOLTIVE Premium SuperPulsed Laser due to non-compliant power cords incompatible with regional electrical outlets. Approximately 203 units were distributed to Australia, Chile, Germany, Hong Kong, Japan, New Zealand, and Singapore.

    Product
    SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1209-2024·2024-03-06

    Colonoscope Recall: Missing Protective Adhesive May Cause Device Failure

    Olympus Corporation is recalling 18 colonoscopes with missing adhesive that protects against physical stress. The missing protective adhesive could allow device failure under vibration, temperature fluctuation, or shock.

    Product
    Colonoscope, Model Number PCF-H180AL.
    Category
    Medical Device
    Distribution
    Distributed nationwide