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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.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Hazard: Recent reports of patient infection.
August 30, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEO
Hazard: The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
August 23, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme
Hazard: Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
August 23, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls UroPass Ureteral Access Sheaths, 5 pieces/box
Hazard: Dilator tips may break in the package and in patients during surgical procedures.
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexib
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibl
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display m
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical int
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in c
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in cli
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical int
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
August 9, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interv
Hazard: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
July 26, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Hazard: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
July 26, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
Hazard: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
July 26, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Hazard: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
July 26, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Hazard: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
July 26, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
Hazard: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
July 26, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Hazard: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
July 26, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Hazard: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
June 28, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu
Hazard: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
June 28, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog
Hazard: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
June 28, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu
Hazard: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
June 28, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog
Hazard: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
May 31, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural le
Hazard: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
May 31, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as
Hazard: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.