The Recall Desk

Manufacturer

Olympus Corporation of the Americas

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

What the numbers show

Total
415
Critical
27
Severe
40
Most recent
2026-09-02

Of the 415 recalls from Olympus Corporation of the Americas we have scored against our rubric, 27 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 40 (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.

126–150 of 415

  • CriticalFDA (Devices)·Z-0057-2026·2025-10-22

    BF-P190 bronchovideoscopes recalled for clarified laser and coagulation instructions

    Olympus is recalling EVIS EXERA III Bronchovideoscope BF-P190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0062-2026·2025-10-22

    BF-Q180-AC bronchovideoscopes recalled for updated laser and coagulation use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type Q180-AC units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0058-2026·2025-10-22

    BF-P60 bronchofiberscopes recalled for updated instructions on laser and coagulation use

    Olympus is recalling OES Bronchofiberscope BF Type P60 units for additional instructions-for-use updates clarifying safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

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

    BF-XT40 bronchofiberscopes recalled for updated therapy equipment use instructions

    Olympus is recalling OES Bronchofiberscope BF Type XT40 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0046-2026·2025-10-22

    BF-1T180 bronchovideoscopes recalled for clarified instructions on therapy equipment

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1T180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0051-2026·2025-10-22

    BF-1TQ180 bronchovideoscopes recalled for updated therapy equipment use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type 1TQ180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0056-2026·2025-10-22

    BF-P180 bronchovideoscopes recalled for updated therapy equipment use instructions

    Olympus is recalling EVIS EXERA II Bronchovideoscope BF Type P180 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0053-2026·2025-10-22

    BF-H190 bronchovideoscopes recalled for updated laser and coagulation use instructions

    Olympus is recalling EVIS EXERA III Bronchovideoscope BF-H190 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2484-2025·2025-09-17

    Aspiration biopsy needles recalled over undetected deformed atraumatic tips

    ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.

    Product
    ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2025·2025-08-27

    Electrosurgical generators recalled over system error causing reboots during use

    The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2025·2025-08-27

    Legacy electrosurgical generators recalled over system error triggering repeated device reboots

    The ESG-410 Legacy Electrosurgical Generator, model WA91307C, is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 434 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2140-2025·2025-07-30

    Green endoscope silicone seals have conflicting sterilization instructions in Japan

    Green Silicone Seals for Accessories, reusable 0-7 FR, model CS-G7, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and mini
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2146-2025·2025-07-30

    Ellik Evacuator non-locking cone has conflicting sterilization instructions in Japan

    The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model 191-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2141-2025·2025-07-30

    Ellik Evacuator glass body has conflicting sterilization instructions in Japan

    The Glass Body for the 194 Ellik Evacuator, model 190A, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2139-2025·2025-07-30

    Reusable endoscope silicone seals have conflicting sterilization instructions in Japan

    Blue Silicone Reusable Silicone Seals 6-12 FR, model CS-B612, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fl
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2142-2025·2025-07-30

    Ellik Evacuator male connector tubing has conflicting sterilization instructions in Japan

    The Tubing for Male Connector 194, Ellik Evacuator, model 190-4, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

    Product
    Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2145-2025·2025-07-30

    Ellik Evacuator locking adapter has conflicting sterilization instructions in Japan

    The Ellik Evacuator Adapter, Locking, model 190-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 5 units affected.

    Product
    Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2144-2025·2025-07-30

    Ellik Evacuator latex bulb has conflicting sterilization instructions in Japan

    The Ellik Latex Bulb, model 194-2, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 48 units affected.

    Product
    Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states