59 results

• Olympus Scope Problems Lead to FDA Import Warning

  October 27, 2026

  Irvin Jackson

  The FDA has issued an import warning involving Olympus medical scopes, claiming the devices continue to suffer quality control problems after years of attempting to address the problems.

• Fujifilm and Olympus Scope Infection Risks Highlight Growing Need for Advanced Disinfection Systems: Report

  October 19, 2026

  Michael Adams

  Concerns about life-threatening infections associated with reusable medical scopes are increasing the need for advanced disinfection technology to protect patients from bacterial contamination.

• Olympus Medical Device Warning Letter Follows FDA Inspections of Six Manufacturing Facilities

  October 16, 2026

  Michael Adams

  Federal regulators are once again examining medical device manufacturing practices at Olympus, following years of safety concerns involving the company's endoscopes and other medical equipment.

• 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.

• Disposable Duodenoscope Elevator Caps Appear Effective in Preventing Infections, Study Finds

  January 25, 2023

  Irvin Jackson

  A new study appears to confirm the effectiveness of disposable elevator caps in preventing duodenoscopes from passing infections from one patient to another.

• 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.

• FDA Calls For Full Transition To Disposable Duodenoscopes Due to Infection Risks

  April 7, 2022

  Irvin Jackson

  The FDA says disposable duodenoscopes should be adopted by every hospital in the U.S. to cut down on infection risks linked to the endoscopic devices.

• Karl Storz Endoscope Recall Issued Over Inadequate Sterilization Process

  April 5, 2022

  Irvin Jackson

  The FDA warns that instructions for cleaning dozens of models of Karl Storz urological endoscopes is insufficient, and could leave patients vulnerable to infections.

• Hospitals Should Transition To Disposable Duodenoscopes Or Those With Disposable Parts: FDA

  January 16, 2020

  Irvin Jackson

  The FDA urges hospitals to start using duodenoscopes that are fully disposable or use disposable parts to protect their patients from potential infections.

• First Fully Disposable Duodenoscope Approved By FDA

  December 16, 2019

  Irvin Jackson

  The FDA has approved the first fully disposable duodenoscope in an effort to eliminate the risk of infections linked to ineffective sterilization techniques.