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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
CriticalFDA
Olympus Corporation Of The Americas
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached...
Surgical Devices·30,140 affected·Dec 18, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Typ...
Surgical Devices·128,608 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·112 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Ty...
Surgical Devices·495,865 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·4,055 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·84,570 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·36,712 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·9,200 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model N...
Surgical Devices·34,325 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Duravent Silicone Ventilation Tube. Model Number: 240075.
Respiratory Devices·984 affected·Nov 19, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 So...
Surgical Devices·1,749 affected·Sep 18, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: O...
Medical Devices·738 affected·Sep 13, 2024
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of t...
Medical Devices·209 affected·Sep 13, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 6105...
Medical Devices·14,093 affected·Sep 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Surgical Devices·279 affected·Sep 4, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Medical Devices·445 affected·Aug 23, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Medical Devices·1,407 affected·Aug 21, 2024
High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of so...
Medical Devices·1,373 affected·Aug 13, 2024
High RiskFDA
Olympus Corporation Of The Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size...
Surgical Devices·100 affected·Jul 1, 2024
High RiskFDA
Olympus Corporation Of The Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size...
Surgical Devices·4,364 affected·Jul 1, 2024
High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Medical Devices·1,585 affected·May 31, 2024
High RiskFDA
Olympus Corporation Of The Americas
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user in...
Surgical Devices·227 affected·Apr 24, 2024
High RiskFDA
Olympus Corporation Of The Americas
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties...
Surgical Devices·150 affected·Mar 7, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-freque...
Surgical Devices·2,525 affected·Mar 1, 2024
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640...
Surgical Devices·0 affected·Feb 17, 2024
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number:...
Surgical Devices·3,361 affected·Feb 17, 2024
High RiskFDA
Olympus Corporation Of The Americas
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Medical Devices·17 affected·Jan 29, 2024
High RiskFDA
Olympus Corporation Of The Americas
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Medical Devices·203 affected·Jan 29, 2024
High RiskFDA
Olympus Corporation Of The Americas
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contaminati...
Medical Devices·877 affected·Jan 16, 2024
High RiskFDA
Olympus Corporation Of The Americas
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS15...
Diagnostic Devices·102,279 affected·Jan 16, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number PCF-H190DL.
Medical Devices·47 affected·Jan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-Q180AL.
Medical Devices·2 affected·Jan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-H180AL.
Medical Devices·36 affected·Jan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number PCF-H180AL.
Medical Devices·18 affected·Jan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-HQ190L.
Medical Devices·97 affected·Jan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number PCF-Q180AL.
Medical Devices·4 affected·Jan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-HQ190I.
Medical Devices·1 affected·Jan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Respiratory Devices·600 affected·Dec 11, 2023
CriticalFDA
Olympus Corporation Of The Americas
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideos...
Surgical Devices·24,300 affected·Dec 8, 2023
High RiskFDA
Olympus Corporation Of The Americas
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Medical Devices·3,001 affected·Dec 4, 2023
CriticalFDA
Olympus Corporation Of The Americas
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Medical Devices·82,200 affected·Dec 1, 2023
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, docu...
Surgical Devices·1,403 affected·Nov 20, 2023
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, docume...
Surgical Devices·271 affected·Nov 20, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>...
Medical Devices·1,639 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices·4,182 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years)...
Medical Devices·126 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>...
Medical Devices·5,232 affected·Nov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 yea...
Medical Devices·8,294 affected·Nov 10, 2023