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Olympus Corporation of the Americas Recalls
414 recalls on record · October 7, 2015 to July 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 6, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
Hazard: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
October 6, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
Hazard: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
October 6, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls BF-P60 OES Bronchofiberscope, Model No. BF-P60
Hazard: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
October 6, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
Hazard: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
October 6, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
Hazard: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
October 6, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Hazard: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
October 6, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls BF-N20 OES Bronchofiberscope, Model No. BF-N20
Hazard: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
September 29, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Hazard: 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 control risk.
September 15, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, P
Hazard: Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
September 8, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue
Hazard: 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 electrical continuity to patient causing tissue burn to critical structures.
August 25, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, ex
Hazard: Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
March 31, 2021Medical DevicesFDA
Olympus Corporation of the Americas recalls Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, do
Hazard: 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 (model MAJ- 2315).
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or flu
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or flu
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid fl
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center,
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultraso
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endo
Hazard: 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.
December 9, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for end
Hazard: 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.
October 28, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, li
Hazard: The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.
October 7, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial num
Hazard: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.
August 26, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Hazard: Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
August 26, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Hazard: Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
June 17, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Hazard: Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
June 10, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Hazard: A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
April 29, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Pleuravideoscope, Model LTF-240
Hazard: There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.
April 29, 2020Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Pleuravideoscope, Model LTF-160
Hazard: There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.