The Recall Desk

Manufacturer

Olympus Corporation of the Americas

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

What the numbers show

Total
423
Critical
27
Severe
41
Most recent
2026-10-07

Of the 423 recalls from Olympus Corporation of the Americas we have scored against our rubric, 27 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 41 (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.

176–200 of 423

  • HighFDA (Devices)·Z-0999-2025·2025-01-29

    Olympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips

    Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2025·2025-01-29

    Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking

    Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.

    Product
    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: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0905-2025·2025-01-22

    Olympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing

    Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2025·2025-01-22

    Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk

    Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.

    Product
    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2025·2024-12-25

    Duravent Silicone Ventilation Tubes recalled for product substitution error

    Olympus is recalling 984 Duravent Silicone Ventilation Tubes (Model 240075) due to the potential that some units may contain incorrect product—specifically 1.32 mm Tiny T Tubes (Model 70240076) instead of the intended product.

    Product
    Duravent Silicone Ventilation Tube. Model Number: 240075.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0620-2025·2024-12-11

    Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing

    Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.

    Product
    EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2025·2024-11-27

    Olympus Gastrointestinal Videoscope Drying Instructions Clarified

    Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.

    Product
    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2025·2024-11-20

    Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage

    Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.

    Product
    Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2025·2024-11-20

    Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness

    Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.

    Product
    Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2025·2024-11-06

    Olympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error

    Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.

    Product
    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2025·2024-11-06

    Olympus Quest Spectrum 3 Fluorescent Imaging System Recalled for EMC Defect

    Olympus is recalling three Quest Spectrum 3 Fluorescent Imaging Systems in Ohio because they do not meet electromagnetic compatibility standards, which could cause malfunction during procedures.

    Product
    Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0229-2025·2024-11-06

    Olympus Endoscopic Flushing Pump Recalled Due to Function Loss

    Olympus is recalling the OFP-2 Endoscopic Flushing Pump due to intermittent loss of function caused by internal component connection failure. Approximately 445 units distributed nationwide are affected.

    Product
    Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0135-2025·2024-10-30

    Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation

    Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.

    Product
    Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    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…
    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
  • 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