The Recall Desk
HighFDA (Devices)·Z-0379-2022·Announced 2021-12-22

Olympus EVIS EXERA II Duodenovideoscope Recalled for Contamination Risk

Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving potential infection risk from device contamination due to adhesive deterioration. No hospitalizations or illnesses have been reported; the hazard is classified as a risk-of-harm product where injury has not yet occurred, meeting the criteria for a High severity score.

Plain-English summary

Olympus Corporation of the Americas is recalling approximately 14,447 units of the EVIS EXERA II DUODENOVIDEOSCOPE (Model TJF-Q180V) distributed nationwide. All serial numbers are affected.

The duodenovideoscope may experience adhesive deterioration or other damage, which can impair the device's ability to be effectively reprocessed. If the device is not properly reprocessed, fluid invasion can occur, leading to endoscope contamination.

A contaminated endoscope can present an infection risk to patients undergoing procedures with the affected device. The FDA has classified this as a Class II recall.

The recalled product

Product
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope
Hazard
  • device-contamination
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers. UDI: 04953170339967

Distribution

Distributed nationwide across the United States.

Related recalls

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