July 03, 2025

In June 2025, the U.S. Food and Drug Administration (FDA) announced import alerts on certain medical devices made by Olympus Medical Systems Corporation in Japan. This means some Olympus devices cannot enter the U.S. until safety and quality problems are fixed.

Devices Affected

The alerts apply to these Olympus devices:

  • Ureterorenoscopes – used in the urinary tract for stone removal or tumor checks.
  • Bronchoscopes – used to look at and treat the airways and lungs.
  • Laparoscopes – used in keyhole surgeries in the abdomen or pelvis.
  • Automated Endoscope Reprocessors – machines that clean and disinfect endoscopes between patients.

Why Did the FDA Take This Step?

The FDA acts when devices do not follow rules. Problems may include:

  • Not meeting quality standards
  • Weak cleaning or sterilization checks
  • Missing or poor documentation
  • Not following approval conditions

Because of this, U.S. Customs can hold shipments until Olympus makes corrections.

Impact on Hospitals and Patients

  • Device Shortages – Some hospitals may not have enough Olympus devices procedures.
  • Infection Risks – Reusable devices must be cleaned well; the alerts stress this safety point.
  • Other Options – Providers may need to use different device brands to continue care.

 

What Providers Should Do

  • Check Devices – Review if you use any affected Olympus products. Watch FDA updates for details.
  • Follow FDA Advice – Carefully clean and disinfect devices as recommended in the FDA letter.
  • Report Problems – Send any issues or safety events to the FDA MedWatch system.

Conclusion

Olympus is expected to fix the problems and restart U.S. shipments. Until then, healthcare providers should:

  • Stay alert for FDA updates
  • Keep strong infection control
  • Use alternative devices if needed