Olympus Corporation of the Americas
232 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Feb 7, 2024
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 ye…
FDA Devices Moderate Feb 7, 2024
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years)…
FDA Devices Moderate Feb 7, 2024
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Mo…
FDA Devices Moderate Jan 24, 2024
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
FDA Devices Moderate Jan 24, 2024
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
FDA Devices Moderate Jan 24, 2024
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
FDA Devices Moderate Jan 17, 2024
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation eq…
FDA Devices Moderate Jan 17, 2024
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equi…
FDA Devices Moderate Dec 20, 2023
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
FDA Devices Critical Nov 15, 2023
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
FDA Devices Moderate Nov 15, 2023
EVIS EXERA III Gastrointestinal Videoscope
FDA Devices Critical Nov 15, 2023
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
FDA Devices Critical Nov 15, 2023
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
FDA Devices Critical Nov 15, 2023
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
FDA Devices Critical Nov 15, 2023
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
FDA Devices Critical Nov 15, 2023
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
FDA Devices Critical Oct 25, 2023
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
FDA Devices Moderate Oct 18, 2023
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surg…
FDA Devices Moderate Oct 11, 2023
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/…
FDA Devices Moderate Oct 11, 2023
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Track…
FDA Devices Moderate Oct 11, 2023
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System …
FDA Devices Moderate Oct 11, 2023
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Ne…
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-3C160.
FDA Devices Moderate Sep 6, 2023
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
FDA Devices Moderate Sep 6, 2023
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
FDA Devices Moderate Sep 6, 2023
Visera Hysterovideoscope Olympus HYF Type V
FDA Devices Moderate Sep 6, 2023
Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Model BF-Q180-AC
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-MP190F.
FDA Devices Moderate Sep 6, 2023
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
FDA Devices Moderate Aug 30, 2023
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEO…
FDA Devices Moderate Aug 23, 2023
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecolog…
FDA Devices Moderate Aug 23, 2023
UroPass Ureteral Access Sheaths, 5 pieces/box
FDA Devices Moderate Aug 16, 2023
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary eq…
FDA Devices Moderate Aug 16, 2023
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their access…
FDA Devices Moderate Aug 16, 2023
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their acces…
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for a…
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomi…
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical st…
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical…
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and…
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical…
FDA Devices Critical Jul 26, 2023
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
FDA Devices Critical Jul 26, 2023
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
FDA Devices Critical Jul 26, 2023