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.

226–250 of 423

  • ModerateFDA (Devices)·Z-1004-2024·2024-02-14

    Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging

    Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.

    Product
    Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0939-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction Issues

    Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.

    Product
    EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0940-2024·2024-02-07

    Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures

    Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.

    Product
    EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0944-2024·2024-02-07

    Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues

    Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.

    Product
    EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0941-2024·2024-02-07

    Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures

    Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.

    Product
    EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0933-2024·2024-02-07

    EZDilate esophageal balloons recalled for inflation failure and device leaking

    Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0942-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk

    Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.

    Product
    EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2024·2024-02-07

    EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk

    Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.

    Product
    EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2024·2024-02-07

    EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk

    Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.

    Product
    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2024·2024-02-07

    EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures

    Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.

    Product
    EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2024·2024-02-07

    Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies

    Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2024·2024-02-07

    Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures

    Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.

    Product
    EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2024·2024-02-07

    Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure

    Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.

    Product
    EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2024·2024-01-24

    Medical Fiber Cleaver System Recalled for Contamination Risk

    Olympus Corporation recalled 236 fiber cleaver units distributed non-sterile but labeled as reusable and autoclavable. Without validated sterilization instructions, use on sterile fiber poses contamination risk.

    Product
    Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2024·2024-01-24

    SOLTIVE SuperPulsed Laser Fibers May Have Breached Sterile Pouch Seals

    Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.

    Product
    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0716-2024·2024-01-24

    Olympus Laser Fiber Stripper Recall Due to Sterilization Validation Gap

    Olympus recalls fiber stripper models sold before 2023 lacking validated sterilization instructions, creating a contamination risk when used on sterile medical fibers.

    Product
    Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2024·2024-01-24

    SOLTIVE SuperPulsed Laser Fibers Recalled for Potential Fiber Breakage During Surgery

    Olympus is recalling 82,200 units of SOLTIVE SuperPulsed Laser Fibers due to instruction inconsistencies that could cause fiber breakage during use, potentially resulting in burns or foreign material in the patient.

    Product
    SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2024·2024-01-17

    Olympus ENDOEYE HD II Videoscope Image Discoloration Recall

    Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2024·2024-01-17

    Olympus ENDOEYE Videoscope Recalled for Reprocessing Instructions Deviations

    Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.

    Product
    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2024·2024-01-17

    Olympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations

    Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.

    Product
    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2024·2023-12-27

    ACMI Roller Bar Electrodes Recall Due to Incorrect Pouch Labeling

    Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes due to incorrect pouch labels. Pouches are mislabeled as Right Angle Cutting Loop Electrodes but contain the correct Roller Bar product.

    Product
    ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0557-2024·2023-12-20

    Olympus tracheal intubation fiberscope recalled due to suction flow specification issue

    Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.

    Product
    TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0191-2024·2023-11-15

    Olympus Bronchovideoscope Recalled for Fire Risk During Cauterization

    Olympus Corporation recalls 13,950 EVIS EXERA II bronchovideoscopes due to risk of endobronchial combustion when high-frequency cauterization is performed with oxygen supplied while the electrode is positioned too close to the endoscope.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0193-2024·2023-11-15

    Olympus Bronchovideoscope Recalled Due to Combustion Risk

    Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.

    Product
    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0190-2024·2023-11-15

    Olympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery

    Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
    Category
    Medical Device
    Distribution
    Distributed nationwide