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All Recalls

Every Olympus Corporation Of The Americas Recall

Sorted by most recent. Click any recall for full details.

266 recalls
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolesc...
Medical Devices·2,991 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices·3,354 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12...
Medical Devices·1,796 affected·Nov 10, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Medical Devices·3,948 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Medical Devices·719 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model...
Medical Devices·15,942 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Medical Devices·13,950 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Medical Devices·32,211 affected·Oct 12, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Gastrointestinal Videoscope
Medical Devices·1,687 affected·Oct 2, 2023
High RiskFDA
Olympus Corporation Of The Americas
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Medical Devices·75 affected·Sep 28, 2023
High RiskFDA
Olympus Corporation Of The Americas
Insufflation unit, UHI-4.
Medical Devices·3,172 affected·Sep 25, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Medical Devices·3,136 affected·Sep 22, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitor...
Medical Devices·45 affected·Sep 14, 2023
High RiskFDA
Olympus Corporation Of The Americas
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) ...
Medical Devices·2,496 affected·Sep 12, 2023
High RiskFDA
Olympus Corporation Of The Americas
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...
Surgical Devices·60,102 affected·Aug 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Uni...
Medical Devices·522 affected·Aug 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigat...
Medical Devices·226 affected·Aug 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Loc...
Medical Devices·9,961 affected·Aug 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Medical Devices·881 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-3C160.
Medical Devices·1,004 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Medical Devices·2,127 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Medical Devices·1,715 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Medical Devices·1,072 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Medical Devices·3,949 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Medical Devices·122 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Medical Devices·4,115 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
Medical Devices·10,801 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Model BF-Q180-AC
Medical Devices·416 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Bronchovideoscope, Models BF-MP190F.
Medical Devices·441 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Medical Devices·6,426 affected·Jul 27, 2023
High RiskFDA
Olympus Corporation Of The Americas
Visera Hysterovideoscope Olympus HYF Type V
Medical Devices·363 affected·Jul 20, 2023
High RiskFDA
Olympus Corporation Of The Americas
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC...
Medical Devices·29,590 affected·Jul 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Medical Devices·4 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Medical Devices·9,684 affected·Jun 8, 2023
High RiskFDA
Olympus Corporation Of The Americas
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological ...
Medical Devices·62,704 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Medical Devices·1 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Medical Devices·284 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Medical Devices·1,535 affected·Jun 8, 2023
High RiskFDA
Olympus Corporation Of The Americas
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ...
Medical Devices·686 affected·May 26, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and ...
Medical Devices·241 affected·May 26, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and...
Medical Devices·1,063 affected·May 26, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventio...
Medical Devices·759 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and...
Surgical Devices·3,692 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for a...
Medical Devices·1,816 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and fo...
Surgical Devices·254 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical inter...
Medical Devices·1,158 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Medical Devices·340 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Medical Devices·45 affected·May 4, 2023