Olympus Corporation of the Americas EVIS EXERA III Gastrointestinal Videoscope Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EVIS EXERA III Gastrointestinal Videoscope
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model No. GIF-1TH190, UDI-DI: 04953170343360, All Serial Numbers.
Products Sold
Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
Olympus Corporation of the Americas is recalling EVIS EXERA III Gastrointestinal Videoscope due to Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Recommended Action
Per FDA guidance
The firm distributed recall notifications via mail to consignees dated 10/02/2023. Consignees are asked to inspect inventory for affected devices, ensure that all reprocessing personnel are aware and knowledgeable of the recall notice and its contents, and acknowledge receipt of the recall notification by returning the enclosed response form via email to olympus5381@sedgwick.com or by fax at 800-913-4345. Customers with any questions about the acknowledgement form are to call 866-912-9544. Customers with any questions about the recall are to contact Cynthia Ow by phone at 647-999-3203 or by email at 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