Recalls · Brand

Olympus Corporation of the Americas recalls

Every recall we track for Olympus Corporation of the Americas — 412 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 9 are rated “stop using now”.

412recalls

Recalls per year, by danger level

Recalls from Olympus Corporation of the Americas peaked in 2023 (90); 412 since 2017. 2% rated “stop using now”.

All FDA recall records for Olympus Corporation of the Americas since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Olympus Corporation of the Americas, by danger level
Year	Stop using now	Use caution	Lower risk	Not yet rated	Total
2017	0	1	0	0	1
2018	0	29	3	7	39
2019	0	3	0	0	3
2020	0	0	17	1	18
2021	1	4	14	0	19
2022	1	6	14	0	21
2023	5	48	32	5	90
2024	0	11	46	1	58
2025	1	14	50	17	82
2026 (to date)	1	18	55	7	81

Most common reasons for Olympus Corporation of the Americas recalls

Devices which did not undergo thermoforming could deform and lose performance.30
Firm is initiating a removal due to continued reports of adverse events.12
Potential for detachment of a distal tip component of the device during use.4
Issue with software algorithm which may lead to overpressure events.3
Potential for rubber fragment detachment during use.2

What to do if you have a recalled Olympus Corporation of the Americas product

Match the model, catalog or lot number on your device to the recall.
Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
Report problems to FDA MedWatch.

See this week’s new recalls.

All Olympus Corporation of the Americas recalls

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Olympus Corporation of the Americas recall questions

How many recalls has Olympus Corporation of the Americas had?

412 recalls from Olympus Corporation of the Americas are on record with U.S. safety agencies, from 2017–2026.

What is the most recent Olympus Corporation of the Americas recall?

Olympus Corporation of the Americas recalls Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih, dated Aug 27, 2026. Every Olympus Corporation of the Americas recall is listed on this page, newest first.

Why are Olympus Corporation of the Americas products recalled?

The most common reasons on record: Devices which did not undergo thermoforming could deform and lose performance. (30); Firm is initiating a removal due to continued reports of adverse events. (12); Potential for detachment of a distal tip component of the device during use. (4); Issue with software algorithm which may lead to overpressure events. (3).

What should I do if I have a recalled Olympus Corporation of the Americas product?

Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.

How do I get alerts for new Olympus Corporation of the Americas recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.

Olympus Corporation of the Americas recalls

Most common reasons for Olympus Corporation of the Americas recalls

What to do if you have a recalled Olympus Corporation of the Americas product

All Olympus Corporation of the Americas recalls

Olympus Corporation of the Americas recalls Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih

Olympus Corporation of the Americas recalls Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.

Olympus Corporation of the Americas recalls Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

Olympus Corporation of the Americas recalls Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

Olympus Corporation of the Americas recalls POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting &

Olympus Corporation of the Americas recalls Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying

Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V-

Olympus Corporation of the Americas recalls Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

Olympus Corporation of the Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

Olympus Corporation of the Americas recalls Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS

Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK

Olympus Corporation of the Americas recalls Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

Olympus Corporation of the Americas recalls Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be

Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic

Olympus Corporation of the Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System -

Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These

Olympus Corporation of the Americas recalls Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog

Olympus Corporation of the Americas recalls Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an

Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Olympus Corporation of the Americas recalls Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate

Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product

Olympus Corporation of the Americas recalls Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T

Olympus Corporation of the Americas recalls Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use

Olympus Corporation of the Americas recalls EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Olympus Corporation of the Americas recalls ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is

Olympus Corporation of the Americas recalls Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform

Olympus Corporation of the Americas recalls Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite

Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog

Olympus Corporation of the Americas recalls Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:

Olympus Corporation of the Americas recalls Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide

Olympus Corporation of the Americas recalls Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to

Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V

Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm,

Olympus Corporation of the Americas recalls Duravent Silicone Ventilation Tube. Model Number: 240075.

Olympus Corporation of the Americas recalls EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

Olympus Corporation of the Americas recalls Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a

Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog

Olympus Corporation of the Americas recalls Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically

Olympus Corporation of the Americas recalls Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product

Olympus Corporation of the Americas recalls Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX,

Olympus Corporation of the Americas recalls Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

Olympus Corporation of the Americas recalls Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)

Olympus Corporation of the Americas recalls Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and

Olympus Corporation of the Americas recalls The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the

Olympus Corporation of the Americas recalls ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation

Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser System, Model TFL-PLS

Olympus Corporation of the Americas recalls EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a

Olympus Corporation of the Americas recalls OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Olympus Corporation of the Americas recalls InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid

Olympus Corporation of the Americas recalls POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such

Olympus Corporation of the Americas recalls Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue

Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L

Olympus Corporation of the Americas recalls SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

Olympus Corporation of the Americas recalls InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.

Olympus Corporation of the Americas recall questions