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RecallsAboutBlog

Olympus Corporation of the Americas

Olympus Corporation of the Americas: 23 recalls listed since January 2026 across FDA; 1 rated high risk.

By year

  • 202623

By agency

  • FDA23

By category

  • Medical Device23

All recalls (23)

Olympus Tripp-Lite DisplayPort Cables

The DisplayPort cable may cause a video dropout or blackout in high-power mode.

Moderate risk, FDA, , Device defect

Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Moderate risk, FDA, , Sterility problem

Olympus EZDilate Endoscopic Balloon Dilators

The Olympus EZDilate Endoscopic Balloon Dilator may have an incorrect inflation chart label.

Moderate risk, FDA, , Labeling error

Olympus BiCOAG Hemostasis Probe

The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.

Moderate risk, FDA, , Device defect

Olympus POWERSEAL Curved Jaw Sealer & Divider

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Moderate risk, FDA, , Labeling error

Olympus High Flow Insufflation Unit - UHI-4

The Olympus High Flow Insufflation Unit can have its front panel display turn off unexpectedly, and air delivery ceases.

Moderate risk, FDA, , Device defect

Olympus 4K UHD LCD Monitor

The Olympus 4K UHD LCD Monitor can have faulty HDMI and DisplayPort connectors, causing image loss or abnormalities.

Moderate risk, FDA, , Device defect

Olympus Evacuators

Some sterilization parameters may not consistently render the devices adequately sterile.

Moderate risk, FDA, , Sterility problem

Olympus Single Use Distal Cover

The Olympus Single Use Distal Cover has a newly designed replacement version.

Moderate risk, FDA, , Device defect

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes

The OER-ELITE Endoscope Reprocessor Connecting Tubes may have lock levers that fail prematurely.

Moderate risk, FDA, , Device defect

Olympus Thunderbeat II Shears w/Ultrasonic Mode

Olympus Thunderbeat II Shears w/Ultrasonic Mode may have a distal tip component that detaches during use.

Moderate risk, FDA, , Device defect

Olympus SOLTIVE Premium and Pro Laser Systems

The Soltive Pro and Premium laser systems may become inoperable and emit smoke or a burning smell.

Moderate risk, FDA, , Device defect

Olympus Cutting Forceps

The cutting forceps have defective welds that can cause the jaw to break during use.

Moderate risk, FDA, , Device defect

Olympus Endoscope Valves and Reprocessors

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Moderate risk, FDA, , Device defect

Olympus ShockPulse-SE Lithotripsy System with Generator

The Olympus ShockPulse-SE Lithotripsy System has a mis-wired component that can cause noise and delay treatment.

Moderate risk, FDA, , Device defect

Olympus Single Use Biopsy Valve

The Olympus Single use Biopsy Valve can detach rubber fragments during use.

Moderate risk, FDA, , Foreign object

Olympus ShockPulse-SE Lithotripsy System Reusable Probes, Single Use Probes and Generator

The ShockPulse-SE Lithotripsy System can remain in a blinking phase waiting to recognize the transducer due to damage to the plug or receptacle.

Moderate risk, FDA, , Device defect

Olympus Resection and Inner Sheaths

Olympus Resection and Inner Sheaths have a ceramic tip that may break.

Moderate risk, FDA, , Device defect

Olympus Cystoscope Outer Sheath

The Olympus Cystoscope Outer Sheath is being removed due to incompatibility with a GreenLight Laser that could damage the device tip.

Moderate risk, FDA, , Device defect

Olympus High Flow Insufflation Unit

The Olympus High Flow Insufflation Unit has a software issue that may lead to overpressure events.

High risk, FDA, , Software defect

Olympus Thunderbeat Surgical Devices

Firm is initiating a removal due to continued reports of adverse events.

Moderate risk, FDA, , Device defect

Olympus Sphincterotomes

Single Use 3-Lumen Sphincterotome V devices may deform and lose performance.

Moderate risk, FDA, , Device defect

Olympus Single Use Electrosurgical Knives KD-640L and KD-645

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Moderate risk, FDA, , Device defect
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