Olympus Corporation of the Americas
232 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Jul 30, 2025
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elit…
FDA Devices Moderate Jun 18, 2025
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-…
FDA Devices Moderate Jun 11, 2025
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
FDA Devices Moderate May 7, 2025
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product D…
FDA Devices Critical Feb 19, 2025
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel…
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model N…
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model …
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…
FDA Devices Moderate Jan 29, 2025
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-05…
FDA Devices Critical Jan 22, 2025
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the inst…
FDA Devices Moderate Dec 25, 2024
Duravent Silicone Ventilation Tube. Model Number: 240075.
FDA Devices Moderate Nov 27, 2024
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Versi…
FDA Devices Moderate Nov 20, 2024
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths…
FDA Devices Moderate Nov 20, 2024
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX…
FDA Devices Moderate Nov 6, 2024
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Devices Moderate Nov 6, 2024
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
FDA Devices Moderate Oct 30, 2024
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentar…
FDA Devices Moderate Oct 30, 2024
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
FDA Devices Moderate Oct 30, 2024
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, …
FDA Devices Moderate Oct 23, 2024
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoThera…
FDA Devices Moderate Sep 18, 2024
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current …
FDA Devices Moderate Aug 14, 2024
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 of the forc…
FDA Devices Moderate Aug 14, 2024
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
FDA Devices Moderate Aug 14, 2024
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 of the forc…
FDA Devices Moderate Jul 10, 2024
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for …
FDA Devices Moderate May 8, 2024
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic…
FDA Devices Moderate Apr 3, 2024
Insufflation unit, UHI-4.
FDA Devices Moderate Apr 3, 2024
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
FDA Devices Moderate Apr 3, 2024
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1…
FDA Devices Moderate Apr 3, 2024
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number PCF-H190DL.
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number CF-Q180AL.
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number CF-H180AL.
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number PCF-H180AL.
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number CF-HQ190L.
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number PCF-Q180AL.
FDA Devices Moderate Mar 6, 2024
Colonoscope, Model Number CF-HQ190I.
FDA Devices Moderate Feb 28, 2024
ESG PK CUTTING FORCEPS, 5MM, 33CM
FDA Devices Moderate Feb 21, 2024
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cov…
FDA Devices Moderate Feb 14, 2024
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
FDA Devices Moderate Feb 14, 2024
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the ri…
FDA Devices Moderate Feb 7, 2024
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) M…
FDA Devices Moderate Feb 7, 2024
EZDilate Wire Guided Balloon 16-17-18. 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 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD…
FDA Devices Moderate Feb 7, 2024
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). …
FDA Devices Moderate Feb 7, 2024