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.

101–125 of 332

  • HighFDA (Devices)·Z-1276-2026·2026-02-11

    Olympus Sphincterotome Devices Recalled for Deformation and Loss of Performance

    Olympus is recalling over 17,600 3-Lumen Sphincterotome V devices because some units did not undergo proper thermoforming, which could cause them to deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2026·2026-02-11

    Olympus Sphincterotome Devices Recalled for Deformation and Performance Loss

    Olympus recalls 999 units of Disposable Triple Lumen Sphincterotomes due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during use.

    Product
    Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2026·2026-02-11

    Olympus Sphincterotome Defective Units Recalled for Potential Device Deformation

    Olympus is recalling CleverCut Single Use 3-Lumen Sphincterotomes (Model KD-V411M-0320) because some units may not have undergone proper thermoforming, potentially causing device deformation and performance loss.

    Product
    Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0570-2026·2025-12-03

    Olympus Ligating Device Recalled Due to Loop Release Failure

    Olympus is recalling the HX-400U-30 ligating device used in endoscopy procedures because the nylon loop may fail to release properly from patient anatomy. The recall affects 7,803 units distributed throughout the United States.

    Product
    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0579-2026·2025-12-03

    Olympus Duodenovideoscope Reprocessing Procedures Updated to Address Reported Infections

    Olympus is updating reprocessing materials and instructions for the TJF-Q190V duodenovideoscope (7,023 units nationwide) following continued reports of infections. Users must follow updated reprocessing instructions closely.

    Product
    Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessorie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2026·2025-11-26

    Olympus Nephrostomy Balloon Catheter Kits Recalled for Wrong Component Size

    Olympus recalled 60 EZDilate Nephrostomy Balloon Catheter kits containing an incorrectly sized 4mm x 4cm urinary tract catheter instead of the correct 8mm x 15cm nephrostomy catheter, affecting healthcare facilities in the US and Canada/Germany.

    Product
    Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0452-2026·2025-11-19

    ShockPulse Lithotripsy Transducer may fail to operate or overheat

    Olympus is recalling the ShockPulse Lithotripsy Transducer because the device may fail to start or stop unexpectedly, and the handpiece may overheat during use. Healthcare providers should discontinue use of affected units.

    Product
    Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2026·2025-11-19

    Olympus Electrosurgical Snare SD-400 Recalled for Sterility Compromise

    Olympus recalled 48,208 units of its Single-Use Electrosurgical Snare SD-400U-10 due to potential sterility compromise from small holes that may occur during packaging or transportation. Non-sterile instruments used in GI procedures could cause infection.

    Product
    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2026·2025-11-19

    Olympus Electrosurgical Snares Recalled for Sterility Compromise

    Olympus Corporation recalls 18,174 electrosurgical snares due to sterility compromise from packaging defects. Small holes in device pouches may allow contamination of the surgical instruments.

    Product
    Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0050-2026·2025-10-22

    Bronchovideoscope instruction updates for safe use with surgical equipment

    Olympus is updating instructions for its BF-1TQ170 bronchovideoscope to clarify safe use when used with laser, argon plasma, and high-frequency therapy equipment.

    Product
    BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0066-2026·2025-10-22

    Bronchoscope instructions updated for safe use with laser and adjunctive equipment

    Olympus is updating instructions for its EVIS EXERA bronchoscope to clarify safe use when combined with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Product
    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0047-2026·2025-10-22

    OES Bronchofiberscope Recalled for Safe Use Instruction Clarification

    Olympus is recalling the OES Bronchofiberscope Model BF-1T60 for instruction updates needed to clarify safe use when combined with laser, argon plasma, and high-frequency therapy equipment.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0061-2026·2025-10-22

    Olympus Bronchovideoscope Instructions Updated for Safe Therapeutic Equipment Use

    Olympus is updating bronchovideoscope instructions for safe use with laser, coagulation, and high-frequency therapy equipment. The Class I recall affects 665 US units.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0051-2026·2025-10-22

    EVIS EXERA II bronchovideoscope instructions clarified for safe use with laser and electrosurgical equipment

    Olympus is updating instructions for the EVIS EXERA II bronchovideoscope to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. This Class I recall affects 215 units distributed nationwide in the US.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0057-2026·2025-10-22

    Olympus Bronchovideoscope Requires Instruction Clarification for Laser and Plasma Equipment

    Olympus is providing clarified instructions for the EVIS EXERA III bronchovideoscope to ensure safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. This FDA Class I recall affects approximately 3,046 units in the US.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0054-2026·2025-10-22

    Olympus Bronchofiberscope Class I Recall for Instructions-for-Use Clarification

    Olympus Corporation is recalling 59 BF-MP60 bronchofiberscopes distributed in the US due to the need for clarification in instructions for use with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0046-2026·2025-10-22

    Olympus Bronchovideoscope IFU Update for Safe Use With Therapeutic Equipment

    Olympus is updating instructions for the EVIS EXERA II Bronchovideoscope (Model BF-1T180) to provide clearer guidance for use with laser, plasma coagulation, and high-frequency therapy equipment. The update affects units distributed nationwide.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0063-2026·2025-10-22

    Olympus Bronchoscope Instructions Clarified for Safe Equipment Use

    Olympus is clarifying instructions for safe use of its EVIS EXERA III bronchoscopes when used with laser, argon plasma coagulation, or high-frequency therapy equipment. This FDA Class I recall affects 916 units in the US.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0049-2026·2025-10-22

    Olympus Bronchoscope Instruction Updates for Safe Therapeutic Equipment Use

    Olympus Corporation recalled the EVIS EXERA III bronchoscope (4,297 US units; 4,290 international units) for instruction clarification regarding safe use with laser, argon plasma coagulation, and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2026·2025-10-22

    Olympus BF-P60 Bronchofiberscope: Clarified Instructions for Safe Use with Surgical Equipment

    Olympus is recalling BF-P60 bronchofiberscopes (FDA Class I) to clarify instructions for safe use when combined with laser, argon plasma, and high-frequency therapy equipment. The recall affects 1,007 units in the US and 5,443 units overseas.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0067-2026·2025-10-22

    Olympus BF-XT40 Bronchofiberscope Recalled for Clarified Use Instructions

    Olympus recalled the BF-XT40 bronchofiberscope to clarify instructions for safe use when combined with laser, argon plasma coagulation, and high-frequency therapy equipment. About 116 units were distributed in the US.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
    Category
    Medical Device
    Distribution
    Distributed nationwide