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.

326–350 of 415

  • ModerateFDA (Devices)·Z-0551-2022·2022-02-09

    Olympus Spiration Valve System mislabeled with incorrect model number

    Olympus Corporation is recalling 35 units of the Spiration Valve System (SVS-V9-00) due to a mislabeled patient charge label indicating model SVS-V7-00 instead. The incorrect label could confuse healthcare providers about which valve was implanted.

    Product
    Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0379-2022·2021-12-22

    Olympus EVIS EXERA II Duodenovideoscope Recalled for Contamination Risk

    Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.

    Product
    EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2022·2021-11-03

    ASC PneumoLiner surgical device recalled due to manufacturing orientation defect

    Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.

    Product
    ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, cons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2021·2021-10-06

    Olympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated

    Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.

    Product
    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2021·2021-10-06

    Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance

    Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.

    Product
    BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2570-2021·2021-10-06

    Olympus BF-XT160 Bronchovideoscope Reprocessing Instructions Updated for FDA Compliance

    Olympus Corporation is issuing updated reprocessing instructions for 293 BF-XT160 bronchovideoscopes to comply with FDA 2015 guidance. Healthcare facilities should implement the new sterilization and disinfection procedures.

    Product
    BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2571-2021·2021-10-06

    BF-P180 EVIS EXERA II Bronchovideoscope Reprocessing Instructions Validation Recall

    Olympus Corporation issued updated reprocessing instructions for 1,177 BF-P180 EVIS EXERA II Bronchovideoscopes to ensure compliance with FDA validation standards for medical device sterilization.

    Product
    BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2572-2021·2021-10-06

    Olympus BF-1T180 Bronchovideoscope Reprocessing Instructions Updated

    Olympus Corporation is issuing updated reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope to comply with FDA 2015 guidance on medical device reprocessing validation.

    Product
    BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2568-2021·2021-10-06

    Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance

    Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.

    Product
    BF-P60 OES Bronchofiberscope, Model No. BF-P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2021·2021-09-29

    Bronchofibervideoscope recalled for potential leak in insertion tube

    Olympus is recalling the EVIS EXERA BF-XT160 bronchofibervideoscope due to a missing gluing step in manufacturing. The affected devices may develop leaks in the insertion tube, posing an infection control risk.

    Product
    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2021·2021-09-15

    Arc Endocuff Vision endoscopic device recalled for packaging seal defects

    Olympus recalls Arc Endocuff Vision endoscopic devices for packaging seal defects that may breach sterile barriers, risking patient infection. Approximately 711,157 units nationwide are affected.

    Product
    Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be att
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2380-2021·2021-09-08

    Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns

    Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.

    Product
    Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2021·2021-08-25

    Soltive Laser Systems recalled for thermal burn injury risk during stone treatment

    Olympus is recalling Soltive laser systems used in urological surgery because exceeding recommended power settings can cause thermal burns to tissue during kidney stone treatment.

    Product
    Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterologica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2021·2021-03-31

    Olympus Recalls TJF-Q190V Duodenoscopes Due to Reported Mucosal Injury

    Olympus is recalling 1,564 TJF-Q190V duodenoscopes and accessories worldwide due to complaints of mucosal injury associated with the forceps elevator region.

    Product
    Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation

    Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning and disinfection instructions.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasoun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide