44 results

• Olympus Scope Infection Concerns Follow Years of FDA Warnings Over Reusable Endoscopes

  July 2, 2026

  Russell Maas

  Federal warnings and enforcement actions involving Olympus and other reusable medical scopes have raised concerns that design flaws may allow bacteria to remain trapped after cleaning, leading to serious infections and product liability lawsuits.

• Olympus Recall Issued Over ShockPulse Device Miswiring: FDA

  March 10, 2026

  Michael Adams

  Federal health officials have announced an updated recall of certain Olympus ShockPulseSE reusable probes, adding to a series of recent recalls involving potentially defective Olympus medical device probes.

• Olympus Endoscope Needle Recall Issued Following Patient Death

  September 23, 2025

  Darian Hauf

  Olympus is recalling select ViziShot 2 FLEX endoscope needles over concerns that components may detach during use and enter a patient’s airway.

• Olympus Endoscope Guide Sheath Recall Issued After Multiple Injuries Linked to Tip Detachment

  March 4, 2025

  Michael Adams

  Federal health officials are announcing a recall of certain Olympus endoscope single use guide sheath kits, after dozens of serious injuries have been reported from tips detaching inside patients during examinations.

• Olympus Endoscope Components Linked to 120 Patient Injuries and 1 Death, FDA Warns

  December 30, 2024

  Martha Garcia

  The FDA is warning that some Olympus endoscope parts may cause serious infections if not cleaned properly, which has already led to more than 100 patient infections and at least one death.

• Olympus Broncoscope Recall Issued After Fire Injuries

  December 20, 2023

  Katherine McDaniel

  An Olympus bronchofiberscope and bronchovideoscope recall affects 18,000 units which could catch on fire during surgical procedures, putting patients at risk.

• Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints

  March 20, 2023

  Martha Garcia

  The FDA has issued another warning letter to Olympus Medical, indicating the company has ignored complaints over problems with its duodenoscopes.

• Olympus Gets FDA Warning Letter Over Failing to Meet Endoscope, Duodenoscope Medical Device Reporting Requirements

  January 12, 2023

  Irvin Jackson

  The FDA has issued warning letters to Olympus over a failure to meet quality control requirements, including reporting of complaints, involving its endoscope products.

• Infections Linked To Reprocessed Urological Endoscopes Under Investigation, FDA Announces

  April 2, 2021

  Irvin Jackson

  The FDA is warning that certain urological endoscopes have been linked to hundreds of infections and several deaths in recent years.

• FDA Calls For Duodenoscope Manufacturers To Create New Easier-To-Sterilize Designs

  August 30, 2019

  Irvin Jackson

  The FDA says current duodenoscope designs cannot be adequately cleaned, and are calling for hospitals to shift to designs that are disposable or have disposable components.