—#203663

Product

EVIS EXERA III Gastrointestinal Videoscope

FDA product code: FDF — Colonoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K112680
Affected lot / code info: Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.

Why it was recalled

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2023-10-02
Posted by FDA: 2023-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203663. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.