Olympus Corporation of the Americas
232 recalls on record · Latest: Feb 11, 2026
FDA Devices Critical Jul 26, 2023
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
FDA Devices Critical Jul 26, 2023
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
FDA Devices Moderate Jun 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
FDA Devices Moderate Jun 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
FDA Devices Moderate Jun 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
FDA Devices Low May 31, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal …
FDA Devices Low May 31, 2023
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial…
FDA Devices Moderate Feb 22, 2023
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, col…
FDA Devices Moderate Oct 19, 2022
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
FDA Devices Moderate Oct 5, 2022
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopi…
FDA Devices Moderate Aug 17, 2022
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
FDA Devices Moderate Jun 29, 2022
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model…
FDA Devices Moderate Jun 29, 2022
Colonovideoscope Model CF-H180AL
FDA Devices Moderate Jun 22, 2022
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
FDA Devices Moderate Jun 22, 2022
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
FDA Devices Moderate Jun 1, 2022
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Devices Moderate May 18, 2022
BF-3C160: EVIS EXERA Bronchovideoscope
FDA Devices Moderate May 18, 2022
BF-MP160F: EVIS EXERA Bronchofibervideoscope
FDA Devices Moderate May 18, 2022
BF-MP60: OES Bronchofiberscope
FDA Devices Moderate May 18, 2022
BF-1TQ180: EVIS EXERA II Bronchovideoscope
FDA Devices Moderate May 11, 2022
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
FDA Devices Moderate Feb 23, 2022
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and…
FDA Devices Moderate Feb 9, 2022
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflat…
FDA Devices Moderate Dec 22, 2021
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
FDA Devices Moderate Nov 3, 2021
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue co…
FDA Devices Moderate Oct 6, 2021
BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
FDA Devices Moderate Oct 6, 2021
BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
FDA Devices Moderate Oct 6, 2021
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
FDA Devices Moderate Oct 6, 2021
BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
FDA Devices Moderate Oct 6, 2021
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
FDA Devices Moderate Oct 6, 2021
BF-N20 OES Bronchofiberscope, Model No. BF-N20
FDA Devices Moderate Sep 29, 2021
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
FDA Devices Moderate Sep 15, 2021
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 …
FDA Devices Moderate Mar 31, 2021
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monito…
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound …
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human…
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile a…
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging…
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, l…
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic sy…
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human…
FDA Devices Moderate Oct 28, 2020
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-…
FDA Devices Moderate Oct 7, 2020
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designe…
FDA Devices Moderate Aug 26, 2020
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
FDA Devices Moderate Jun 10, 2020
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
FDA Devices Moderate Apr 29, 2020
Olympus Pleuravideoscope, Model LTF-160
FDA Devices Moderate Oct 23, 2019
Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine …
FDA Devices Moderate Mar 20, 2019
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastroin…
FDA Devices Moderate Mar 20, 2019
Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestin…
FDA Devices Moderate Oct 10, 2018