Brand

Olympus Corporation of the Americas: official recall notices

8 official recall or safety notices on this site name Olympus Corporation of the Americas, dated between 2024-01-16 and 2026-02-27. They were issued by 1 authority: US FDA — Medical Devices (8).

Countries where the notices were issued: United States (8).

Name as written in the notices: Olympus Corporation of the Americas. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

Notices by year

Year	Notices
2026	1
2025	2
2024	5

Notices by authority

Authority	Notices
US FDA — Medical Devices	8

All notices

Date	Authority	Product	Hazard (as classified)
2026-02-27	US FDA — Medical Devices	Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/	—
2025-10-17	US FDA — Medical Devices	Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro	—
2025-05-05	US FDA — Medical Devices	Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V	—
2024-09-13	US FDA — Medical Devices	EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat	—
2024-08-13	US FDA — Medical Devices	Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v	—
2024-03-07	US FDA — Medical Devices	POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur	—
2024-03-01	US FDA — Medical Devices	Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue	—
2024-01-16	US FDA — Medical Devices	InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Mod	—

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