EVIS EXERA III Duodenovideoscope (Olympus) – Contamination Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
Products Sold
UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
Olympus Corporation of the Americas is recalling Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V due to Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual clean. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Recommended Action
Per FDA guidance
Olympus notified consignees on 05/05/2025 via "URGENT Medical Device Correction" letter. Consignees were instructed to carefully review the notification, ensure all reprocessing and endoscopy unit personnel are completely knowledgeable and thoroughly trained on the updated reprocessing instructions, replace any copies of the reprocessing manual with the updated version (RC8415_02), complete and return the response form to recall web portal: https://olympusamerica.com/recall, enter the recall number: "0471" and complete the form as instructed, and forward the notification to affected customers if the affected product has been further distributed. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026