Brand
Olympus Corporation Of The Americas Recalls
266 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Olympus Corporation Of The Americas.
266Total Recalls
37Critical
3.7MUnits Affected
Mar 25, 2026Most Recent
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 Devices30,140 affectedDec 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 Devices128,608 affectedNov 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 Devices112 affectedNov 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 Devices495,865 affectedNov 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 Devices4,055 affectedNov 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 Devices84,570 affectedNov 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 Devices36,712 affectedNov 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 Devices9,200 affectedNov 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 Devices34,325 affectedNov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Duravent Silicone Ventilation Tube. Model Number: 240075.
Respiratory Devices984 affectedNov 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 Devices1,749 affectedSep 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 Devices738 affectedSep 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 Devices209 affectedSep 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 Devices14,093 affectedSep 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Surgical Devices279 affectedSep 4, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Medical Devices445 affectedAug 23, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Medical Devices1,407 affectedAug 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 Devices1,373 affectedAug 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 Devices100 affectedJul 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 Devices4,364 affectedJul 1, 2024
High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Medical Devices1,585 affectedMay 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 Devices227 affectedApr 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 Devices150 affectedMar 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 Devices2,525 affectedMar 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 Devices0 affectedFeb 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 Devices3,361 affectedFeb 17, 2024
High RiskFDA
Olympus Corporation Of The Americas
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Medical Devices17 affectedJan 29, 2024
High RiskFDA
Olympus Corporation Of The Americas
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Medical Devices203 affectedJan 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 Devices877 affectedJan 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 Devices102,279 affectedJan 16, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number PCF-H190DL.
Medical Devices47 affectedJan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-Q180AL.
Medical Devices2 affectedJan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-H180AL.
Medical Devices36 affectedJan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number PCF-H180AL.
Medical Devices18 affectedJan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-HQ190L.
Medical Devices97 affectedJan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number PCF-Q180AL.
Medical Devices4 affectedJan 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Colonoscope, Model Number CF-HQ190I.
Medical Devices1 affectedJan 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 Devices600 affectedDec 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 Devices24,300 affectedDec 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 Devices3,001 affectedDec 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 Devices82,200 affectedDec 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 Devices1,403 affectedNov 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 Devices271 affectedNov 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 Devices1,639 affectedNov 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 Devices4,182 affectedNov 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 Devices126 affectedNov 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 Devices5,232 affectedNov 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 Devices8,294 affectedNov 10, 2023