The Recall Desk

Manufacturer

Olympus Corporation of the Americas

332 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.

226–250 of 332

  • 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 tho
    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 t
    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-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
  • SevereFDA (Devices)·Z-0192-2024·2023-11-15

    Olympus Bronchovideoscopes Recalled for Endobronchial Combustion Risk

    Olympus is recalling bronchovideoscopes nationwide due to a risk of combustion inside the bronchial passages during high-frequency cauterization if oxygen is supplied or the electrode is positioned too close to the scope's tip.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0189-2024·2023-11-15

    Five Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk

    Olympus is recalling 15,942 bronchovideoscope units nationwide due to endobronchial combustion risk during cauterization procedures with oxygen supply. The hazard occurs when the electrode of the surgical accessory is positioned too close to the scope's distal end.

    Product
    BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0194-2024·2023-11-15

    FDA Recalls Olympus EVIS EXERA III Bronchovideoscope for Combustion Risk

    Olympus Corporation is recalling 3,948 EVIS EXERA III bronchovideoscope units nationwide due to risk of combustion during electrosurgical procedures when high-frequency cauterization is used with oxygen supply.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
    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
  • HighFDA (Devices)·Z-0288-2024·2023-11-15

    EVIS EXERA III Gastrointestinal Videoscope Recalled Due to Sterilization Failures

    Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.

    Product
    EVIS EXERA III Gastrointestinal Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2024·2023-10-25

    Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications

    Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.

    Product
    Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2024·2023-10-18

    Surgical instrument button malfunction may extend operative time

    Olympus THUNDERBEAT surgical instruments may have a blue seal button that remains engaged after release, potentially extending surgery time. The company is recalling 271 affected units nationwide.

    Product
    THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2024·2023-10-18

    Olympus THUNDERBEAT surgical instrument blue seal button may fail to return to neutral

    Olympus is recalling 2,496 units of THUNDERBEAT Model TB-0535FCS surgical instruments because the blue seal button may fail to return to neutral position after release, potentially causing prolonged surgery. The recall affects units distributed nationwide.

    Product
    THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nisse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2662-2023·2023-10-11

    Veran Endobronchial Navigation Devices Recalled for Design Non-Conformance and EMC Issues

    Olympus Corporation recalls Veran endobronchial navigation devices due to manufacturing non-conformances and insufficient electromagnetic compatibility. Approximately 6,318 units distributed worldwide are affected.

    Product
    Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2660-2023·2023-10-11

    Veran Endobronchial Navigation Devices Recalled for Manufacturing Non-conformance

    Olympus is recalling Veran endobronchial navigation devices (6,484 units) worldwide due to manufacturing non-conformances and insufficient evidence of adequate electromagnetic compatibility. The devices may not function acceptably in environments with electromagnetic interference.

    Product
    Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2023·2023-10-11

    Medical Navigation System Recalled for Manufacturing and Electromagnetic Compatibility Defects

    Olympus Veran percutaneous navigation systems are recalled due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence, affecting approximately 9,961 units distributed worldwide.

    Product
    Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2664-2023·2023-10-11

    Veran Endobronchial Navigation System: Manufacturing and EMC Defects

    Olympus is recalling Veran endobronchial navigation systems due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence. Devices may malfunction or interfere with other medical equipment.

    Product
    Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2663-2023·2023-10-11

    Veran Navigation System Biopsy Needle Devices: Electromagnetic Compatibility Issue

    Olympus is recalling 522 units of Veran navigation system biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility testing. Devices may not function properly in certain electromagnetic environments.

    Product
    Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2023·2023-10-11

    Olympus SPiN Thoracic Navigation System Models Recalled for EMC Non-Conformance

    Olympus is recalling SPiN Thoracic Navigation System and related models due to manufacturing non-conformances and insufficient electromagnetic compatibility (EMC) evidence. The devices may malfunction in certain electrical environments.

    Product
    Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2467-2023·2023-09-06

    EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports

    Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.

    Product
    EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2023·2023-09-06

    Olympus Bronchovideoscope Models Risk Device Lodging in Airway

    Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.

    Product
    Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2023·2023-09-06

    Olympus Tracheal Intubation Fiberscope may lodge in endotracheal tube connector

    Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.

    Product
    Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2491-2023·2023-09-06

    Olympus Bronchovideoscope Models Recalled Due to Lodging Risk in Connectors

    Olympus is recalling 1,072 units of Bronchovideoscope Models BF-MP160F, BF-XP160F, and BF-XP60 distributed nationwide. The devices can become lodged in the endotracheal tube connector due to oversized endoscope diameter.

    Product
    Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2023·2023-09-06

    Olympus Bronchovideoscope Recalled for Risk of Lodging in Airway Connector

    Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-3C160.
    Category
    Medical Device
    Distribution
    Distributed nationwide