Overview of recall records associated with Olympus Corporation of the Americas, including dates, categories and classifications where available.
Classification mix: Class II: 217, Class I: 14, Class III: 2.
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber…
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of…
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision…
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision…
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision…
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the…
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can…
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will…
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection…
Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or…
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover…
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
This page summarizes recall records in which the official source identifies Olympus Corporation of the Americas as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
