Manufacturer
423 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.
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.
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.
Olympus Corporation recalled 1,386 units of Disposable Grasping Forceps FG-51D due to noncompliance with force standards for opening and closing the devices.
The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.
Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.
Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.
Olympus bronchovideoscopes are recalled due to updates required for proper sterilization and reprocessing procedures. Healthcare providers must follow new instructions for chemical disinfection and ETO gas sterilization.
Olympus is updating instructions for reprocessing and sterilizing BF-MP60 bronchofiberscopes to ensure proper procedures. All 60 units distributed nationwide are affected.
Olympus recalls the GF-UC140P-AL5 ultrasonic gastrovideoscope nationwide because it is no longer compatible with the OER-Pro reprocessing system, creating an infection control risk to patients.
Olympus OER-Elite Endoscope Reprocessors may have incorrectly assembled detergent and alcohol tank tubing, causing solutions to be dispensed in reversed cycles. This results in ineffective endoscope disinfection and potential patient exposure to residual detergent.
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.
Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.
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.
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.
Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.
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.
Olympus Corporation is issuing updated reprocessing instructions for the BF-1T60 bronchofiberscope to comply with FDA 2015 guidance on device reprocessing in health care settings.
Olympus Corporation is recalling 431 BF-Q180-AC EVIS EXERA II Bronchovideoscopes to issue validated reprocessing instructions aligned with FDA 2015 guidance.
Olympus is updating reprocessing instructions for the BF-N20 Bronchofiberscope to comply with FDA 2015 guidance on medical device reprocessing validation.
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.
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.
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.
Olympus Corporation issued updated reprocessing instructions for the BF-XP60 bronchofiberscope to align with FDA 2015 guidance on medical device reprocessing validation and labeling.
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.
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.
Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.
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.