Z-0288-2024Class II

EVIS EXERA III Gastrointestinal Videoscope

Name: Z-0288-2024 EVIS EXERA III Gastrointestinal Videoscope
Creator: Olympus Corporation of the Americas
Published: 2023-10-02
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-10-02 / Open, Classified / root cause: sterility

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA III Gastrointestinal Videoscope on 2023-10-02. FDA classified it as Class II and gives the reason as "Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0288-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-02
Posted: 2023-11-09
Recalling firm: OLYMPUS Corporation of the Americas
Product: EVIS EXERA III Gastrointestinal Videoscope
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
Reason for recall: Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Root cause tag: sterility
FDA 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 [email protected] 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 [email protected].
Quantity in commerce: 1687 units
Distribution: Nationwide Distribution.
Product codes and lots: Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0288-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0288-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code FDF

K112680Class IIEvis Exera III Video SystemOlympus Medical Systems Corporation / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)