FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: EVIS EXERA III Gastrointestinal Videoscope
- Recall number
- Z-0288-2024
- Recalling firm
- Olympus Corporation of the Americas
- Product
- EVIS EXERA III Gastrointestinal Videoscope
- Status
- Open, Classified
- Initiated
- 2023-10-02
- Posted
- 2023-11-09
- Terminated
- not on file
- Reason
- Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
- Root cause
- Reprocessing Controls
- Action
- 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.
- Quantity
- 1687 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
- 510(k) numbers
- ["K112680"]
- PMA numbers
- not on file
- Product code
- FDF
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28